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Anti-Covid-Nasenspray, die ersten Ergebnisse der Studie
Die Ergebnisse scheinen gut zu sein", sagte der Direktor der Abteilung für Hygiene der Universität Genua, Prof. Giancarlo Icardi, auch wenn es sich vorerst nur um eine kleine Erwartung handelt. Der vollständige Bericht wird bis Ende September vorliegen".
Das Nasenspray besteht im Wesentlichen aus einer wässrigen Waschlösung, die hypochlorige Säure enthält, eine antimikrobielle Substanz, die auch von den Zellen unseres Immunsystems produziert wird. Bei Coronavirus-positiven Patienten mit einem milden Krankheitsbild würde es die Viruslast in den oberen Atemwegen wirksam reduzieren.
Anti-Covid-Nasenspray, die Wirkstoffe
Der Wirkmechanismus des AOS2020-Sprays beruht auf der Waschwirkung der Lösung, die, unterstützt durch die starke antimikrobielle Wirksamkeit der unterchlorigen Säure, in der Lage ist, Viren und Bakterien, einschließlich Sars-CoV-2 und seiner verschiedenen Mutationen, in weniger als einer Minute mechanisch zu entfernen und abzutöten, ohne die Schleimhäute von Nase und Rachen zu reizen. Die Aufbewahrung der Lösung erfordert keine besonderen Vorsichtsmaßnahmen und ist bei Raumtemperatur zwischen 5 und 25 °C bis zu zwei Jahre haltbar.
Hypochlorige Säure ist eine Substanz, die von den Zellen unseres Immunsystems produziert wird, um Infektionen zu bekämpfen, die durch verschiedene Mikroorganismen verursacht werden. Sie wurde dank Tehclo, einer Nanotechnologie, die sie in einer wässrigen Lösung "einfängt" und auf den Menschen übertragbar macht, rein und stabil gemacht. Die neue Technologie wurde von einem italienischen Team, bestehend aus Paolo Galfetti, Roberto De Noni und Giorgio Reiner, von der italienisch-schweizerischen Firma APR Applied Pharma Research s.a. konzipiert und entwickelt, die die innovative Nanotechnologie patentiert hat.
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To open the online version please click here.
Dear Sir or Madam,
We would like to draw your attention to the following ad hoc announcement pursuant to Art. 53 LR of RELIEF THERAPEUTICS Holding AG:
Relief Reports that its U.S. Collaboration Partner has Announced a Second Favorable Safety Report for ZYESAMI™ (RLF-100TM/aviptadil) in the NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19
Geneva, Switzerland, September 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release providing a safety update on ZYESAMI™ (RLF-100TM/aviptadil) which is being tested in the ACTIV-3b/TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) phase three study sponsored by the National Institutes of Health (NIH). According to the press release, in its second scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of 231 patients and recommended continued enrollment. The related NRx press release can be accessed through the following link.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
§
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RLF-100TM (aviptadil) will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, (ii) whether RELIEF THERAPEUTICS Holding SA can satisfactorily resolve its ongoing disputes with NeuroRx without litigation, (iii) whether RELIEF THERAPEUTICS Holding SA will prevail in any litigation action with NeuroRx over the terms of the Collaboration Agreement, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
+++ End of announcement +++
MC Services AG
Handelsregister/Commercial Register: Amtsgericht Augsburg HRB 2117
Vorstand/Management Board: Raimund Gabriel, Anne Hennecke
Aufsichtsrat/Supervisory Board: Johannes Gabriel (Vorsitzender/Chairman)
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1
Ad hoc announcement pursuant to Art. 53 LR
Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research,
Reports Data Published in the Peer Reviewed Journal of Wound Care, Indicating
That Nexodyn® AOS Is a Highly Effective Treatment to Support Wound Healing of
Hard-to-Heal Leg Ulcers
As an Active Cleanser, Nexodyn® AOS Shows Superior Wound Healing Performance Compared to
Standard of Care
Geneva, Switzerland, September 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious
diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma
Research SA (“APR”), reported data published in the peer reviewed Journal of Wound Care, indicating that
the company’s Nexodyn® acid-oxidizing solution (AOS), developed with APR’s proprietary Tehclo®
technology, was found to be a highly effective treatment to support wound healing in infected or non-
infected hard-to-heal leg ulcers. The data also confirmed the safety and tolerability of Nexodyn®.
Conducted by Robert Strohal, M.D., Professor and Department Head, Department of Dermatology,
Federal Academic Teaching Hospital of Feldkirch, Austria, and colleagues, the open-label, randomized
controlled MACAN study was conducted at two centers is Austria. A total of 50 patients were enrolled,
with either infected or non-infected hard-to-heal leg ulcers of different etiology. Patients were treated for
six weeks either with Nexodyn® AOS or standard of care (SOC) wound dressings.
In the patient group treated with Nexodyn® AOS, wounds exhibited a faster and more pronounced wound
size reduction compared with wounds in the SOC group. Additionally, compared to SOC, the treatment
group showed a markedly greater percentage of complete healing of hard-to-heal ulcers by the end of the
study period (32% versus 8%, respectively). Furthermore, Nexodyn® demonstrated its ability to
significantly reduce the wound pH (p<0.0001) and thus promote a faster healing process. In all patients
with infected leg ulcers, local infection was overcome more rapidly with Nexodyn® AOS treatment.
Overall, the efficacy of Nexodyn® AOS was found to be not only non-inferior but superior to SOC wound
dressings.
“The publication of the MACAN study reconfirms the effectiveness of Nexodyn® AOS, developed with our
proprietary, globally patented Tehclo® nanotechnology platform, versus SOC, providing further evidence
of its unique ability to significantly reduce healing time, protect from risk of infection and reduce clinical
2
signs of local infection,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief
Europe. “Importantly, the study showed that Nexodyn® AOS, with its antimicrobial properties, is able to
control infection as a stand-alone treatment and that the reduction of the pH in the wound bed is directly
associated with wound healing. Additionally, by restoring the prerequisites of the physiological healing
process, use of Nexodyn® AOS can meaningfully help to reinitiate chronic wound closure. The published
results show that Nexodyn® AOS is not only non-inferior, but is, in fact, superior to wound dressing
standard of care, clearly establishing Nexodyn® AOS, as an important treatment for chronic hard-to-treat
wounds.”
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “The marked improvement in wound
healing reported in the MACAN study also bodes well for APR-TD011, developed with the same Tehclo®
platform as Nexodyn® AOS, which is designed as a complete treatment for epidermolysis bullosa (EB)
patients to prevent or reduce skin lesion infections and inflammation through modulation of the wound
microenvironment to support a faster physiological wound healing. APR TD-011 was granted Orphan Drug
Designation and may become an important treatment option for the estimated 250,000 EB patients
worldwide.”
About Nexodyn® Acid-Oxidizing Solution (AOS)
Nexodyn® Acid-Oxidizing Solution (AOS) is a Tehclo®-based product proven to restart wound healing in
stalled wounds by creating the ideal microenvironment to sustain the physiological healing process.
A wealth of evidence and real-world experience consistently show accelerated closure with reduced
infection rates and less wound-associated pain.
Nexodyn® AOS is a solution with three main features: highly pure and stabilized hypochlorous acid (HClO
>95% of free chlorine species), acidic pH (2.5 – 3.0) and high Reduction-Oxidation Potential (ORP 1.000 –
1.200 mV). The product is a sprayable solution with ancillary antimicrobial properties intended for use in
the debridement, irrigation, cleansing and moistening of acute and chronic wounds (e.g., diabetic foot
ulcers, pressure ulcers, and vascular ulcers), post-surgical wounds, burns and other lesions. The product
is certified in the European Union as a Class III medical device.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
3
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and
development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's
filings with the SIX, which could cause the actual results, financial condition, performance or achievements
of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding
SA is providing this communication as of this date and do not undertake to update any forward-looking
statements contained herein as a result of new information, future events or otherwise.
.
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https://www.science.org/news/2020/05/...ehind-potential-covid-19-drug
Allen ein schönes Wochenende !!! :-)
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zur Auswertung und sie ( FDA ) wartet auf Rückmeldung der Sachbearbeiter , die unsere Studie
betreuen . Verwunderlich ist wer so kurz vor der Zielgeraden hinwirft bzw. den Kurs so drückt
und Kleinanleger verunsichert . Bin immer noch zu 100% von Relief und Aviptadil überzeugt . VIP
wird seinen Weg in der Medizin gehen und die Pipeline zur Verwendung verschiedenster Lungen-
erkrankungen wartet nur darauf das Aviptadil zur Anwendung kommt ! Die EUA wird auf kurz oder
lang erteilt und dann tanzt der Bär ! Der Kurs ist aktuell nur eine Momentaufnahme und spiegelt
nicht den tatsächlichen Wert von Relief Therapeutics wieder .
https://clinicaltrials.gov/ct2/history/...C=Side-by-Side#StudyPageTop
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Die Erklärung des CEO hätte leicht mit 15 Punkten geschrieben werden können, die als eigene nummerierte Aufzählungspunkte vermerkt sind. Wir haben ein enormes Potenzial! Wissen Sie, was Sie besitzen. Dies ist keine Finanzberatung. NRXP stark!
1. Die Teilnehmer des COVID-19-Workshops der FDA/NIH hörten den Vortrag von Dr. Francis Collins über ACTIV3-b. Er bezeichnete ZYESAMI als eine der wenigen verbleibenden brauchbaren Behandlungsmöglichkeiten unter den 750 von den NIH geprüften.
2. Tatsächlich ist ZYESAMI das einzige Medikament, das unseres Wissens derzeit von den NIH an schwerstkranken Patienten, die an Beatmungsgeräten hängen, getestet wird.
3. Im Laufe des letzten Jahres haben wir eine vollständige IND-Datei (Investigational New Drug) zusammengestellt, und die FDA hat uns schriftlich mitgeteilt, dass für die Einreichung eines NDA-Antrags (New Drug Application) keine zusätzlichen nichtklinischen Daten zur Toxizität erforderlich sind. Diese Grundlage ermöglicht die Untersuchung wichtiger zusätzlicher Indikationen für ZYESAMI.
4. Wir arbeiten mit Mannkind (Nasdaq:MNKD) zusammen, um ihr Trockenpulver-Insulinverabreichungssystem für die inhalative Verabreichung von Aviptadil zu adaptieren, um ein bei Raumtemperatur stabiles, einfach zu handhabendes Medikament zu erhalten.
5. Wir arbeiten auch mit TFF Pharmaceuticals (Nasdaq:TFFP) zusammen, um eine langzeitstabile, rekonstituierbare Form von ZYESAMI zu entwickeln.
6. Obwohl es keine gesetzlich vorgeschriebene Frist gibt, innerhalb derer die FDA eine Entscheidung über die EUA treffen muss, teilte uns der Projektleiter, der unseren EUA-Antrag betreut, am Freitag, dem 1. Oktober, mit, dass die Prüfung noch nicht abgeschlossen ist und die FDA auf die Stellungnahme einiger ihrer Mitarbeiter wartet.
7. Im Zuge der Entwicklung randomisierter prospektiver Daten zur Unterstützung des EUA-Antrags sind wir der Ansicht, dass wir die Anforderungen für die Breakthrough Therapy Designation erfüllt haben und haben diesen Antrag bei der FDA eingereicht.
8. Möglicherweise erfüllen wir auch die gesetzlichen Anforderungen für eine beschleunigte Zulassung gemäß Abschnitt 506c des Food, Drug and Cosmetics Act, basierend auf den Ergebnissen von zwei separaten Studien, die eine statistisch signifikante Reaktion auf zwei Biomarker zeigen: Respiratory Distress Ratio und Zytokin IL-6.
9. Wie Sie wissen, ist ZYESAMI eines von drei Produkten in unserer Pipeline, die im Jahr 2022 zugelassen werden könnten; die beiden anderen sind NRX-101 und der Impfstoff BriLife. Jedes Produkt hat das Potenzial, unzählige Leben zu retten und einen erheblichen Wert für die Aktionäre zu schaffen. Wir werden in künftigen Mitteilungen über BriLife und NRX-101 berichten.
Im kommenden Jahr beabsichtigen wir, klinische Studien für die folgenden Indikationen einzuleiten:
10. COVID "Longhauler"-Syndrom: Millionen von Amerikanern leiden nach wie vor unter einer verminderten Atemkapazität und benötigen zu Hause Sauerstoff, um einen angemessenen Sauerstoffgehalt im Blut aufrechtzuerhalten.
11. Sarkoidose: Diese chronische Lungenkrankheit betrifft 185.000 Amerikaner und führt bei 1 bis 5 % der Betroffenen zu Lungenbehinderungen und zum Tod. Die FDA hat Sarkoidose als eine seltene Krankheit anerkannt.
12. Akutes Atemnotsyndrom (Acute Respiratory Distress Syndrome, ARDS): Diese Krankheit hat Prof. Sami Said in den letzten Jahren seiner Laufbahn zusammen mit unserem leitenden Prüfarzt Dr. J. Georges Youssef vom Houston Methodist Hospital erstmals behandelt. Sieben der acht Patienten, die sie im Stonybrook University Hospital behandelten, überlebten die Intensivstation und sechs konnten das Krankenhaus erfolgreich verlassen.
13. Checkpoint-Inhibitor-Pneumonitis: Eine der vielversprechendsten Entwicklungen in der Krebschemotherapie ist die Einführung von Checkpoint-Inhibitoren, deren bekanntestes Beispiel Keytruda® (Pembrolizumab) ist. Diese Medikamente haben sich bei zuvor hoffnungslosen bösartigen Erkrankungen als vielversprechend erwiesen, verursachen jedoch eine äußerst unangenehme Lungenentzündung (Pneumonitis), die für die Patienten und ihre Familien eine Herausforderung darstellt. In der medizinischen Fachliteratur wird berichtet, dass mit inhalativem Aviptadil eine erhebliche Linderung erzielt werden kann.
14. Konservierung der Spenderlunge vor und nach der Transplantation: Es gibt eine umfangreiche präklinische Literatur über die Wirkung von Aviptadil zum Schutz der Spenderlunge sowohl außerhalb des Körpers als auch nach der Transplantation. Dr. Youssef hat einige Lungentransplantationspatienten im Rahmen einer vom Prüfarzt gesponserten IND mit ermutigenden Ergebnissen behandelt.
15. Chronisch obstruktive Lungenerkrankung (COPD): Es wurden uns sehr vielversprechende Daten über das Potenzial von Aviptadil zur Verbesserung der Symptome bei Patienten mit fortgeschrittener COPD mitgeteilt. Mehr als 15 Millionen Amerikaner leiden an COPD, und die Behandlung ist derzeit weitgehend auf
Behandlung beschränkt sich derzeit weitgehend auf den Einsatz von inhalativen Steroiden und Bronchodilatatoren. Unser Produktionspartner, Nephron Pharmaceuticals, ist einer der landesweit größten Anbieter von maßgeschneiderten inhalativen Arzneimitteln.
**Wir haben also noch viel Arbeit vor uns und viele Millionen Patienten, die ZYESAMI benötigen könnten.
Übersetzt mit www.DeepL.com/Translator (kostenlose Version)
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Ad hoc announcement pursuant to Art. 53 LR
Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Filing of New Drug
Application for ACER-001 to Treat Urea Cycle Disorders
FDA sets PDUFA target action date of June 5, 2022
NEWTON, MA and GENEVA, SWITZERLAND – October 6, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER)
(“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing
the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for the treatment of patients
with Urea Cycle Disorders (UCDs). The FDA has assigned a Prescription Drug User Fee Act (PDUFA)
target action date of June 5, 2022.
Acer’s 505(b)(2) NDA is supported by results from two previously announced bioequivalence (BE) trials
in which ACER-001 showed similar relative bioavailability for both phenylbutyrate (PBA) and
phenylacetate (PAA), the active metabolite of sodium phenylbutyrate, compared to the reference
listed drug, BUPHENYL® (sodium phenylbutyrate).
"With FDA commencing a substantive review of our NDA, ACER-001 is one step closer to potentially
providing an alternative treatment option for patients with UCDs," said Chris Schelling, Chief Executive
Officer and Founder of Acer. "We look forward to working with the FDA during their review of our
application. In addition, we continue to collaborate with our partners to ensure we are well positioned
to support a successful commercial launch of ACER-001, subject to FDA approval.”
Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “Our collaboration with Acer is
thriving and we are pleased with the progress they have made in advancing ACER-001. In parallel with
Acer’s activities, we continue to execute on our global commercial strategy for ACER-001 which
includes our intended submission of a Marketing Authorization Application (MAA) for the treatment of
patients with UCDs in Europe in Q2/Q3 2022.”
Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/...cycle-disorders-ucds/
ACER-001 is an investigational product candidate which has not been approved by FDA, the European
Medicines Agency (EMA), or any other regulatory authority. There is no guarantee that this product
candidate will receive regulatory authority approval in any territory or become commercially available
for the indications under investigation.
Ad hoc announcement pursuant to Art. 53 LR
About UCDs
UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six
enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the
bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy,
somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches,
confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common
symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric
symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit
ammonia production in conjunction with medications that provide alternative pathways for the
removal of ammonia from the bloodstream. Some patients may also require individual branched-chain
amino acid supplementation.
Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and
BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium
phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular
Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be
effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with
treatment is common. Reasons referenced for non-compliance associated with some available
medications include unpleasant taste, frequency with which medication must be taken, required
number of pills, and the high cost of the medication.3
About ACER-001
ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of
metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 is a nitrogen-binding
agent in development for use as adjunctive therapy in the chronic management of patients with UCDs
involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or
argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral
administration consisting of a core center, a layer of active drug, and a taste-masked coating designed
to avoid the bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH
of the stomach. Acer is also being developed for MSUD and has been granted orphan drug designation
by the FDA for this indication. ACER-001 is an investigational product candidate which has not been
approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.
About Acer Therapeutics Inc.
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of
therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s
pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn
errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD);
ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for
treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen
(COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious
diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively
de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data,
mechanistic differentiation and/or accelerated paths for development through specific programs and
procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License
Ad hoc announcement pursuant to Art. 53 LR
Agreement with Relief for development and commercialization of ACER-001. For more information,
visit www.acertx.com.
About RELIEF THERAPEUTICS Holding SA
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the
U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification
strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer
Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and
immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment
of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed
acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse
pipeline of marketed and development-stage programs, a commercial infrastructure in selected
European countries and an internal, R&D capability, which Relief hopes to leverage for both internal
pipeline products as well as for third party product development on a fee for service basis.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted
in the U.S. on OTCQB under the symbol RLFTF. For more information, visit
www.relieftherapeutics.com. Follow Relief on LinkedIn.
References
1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University
of Washington, Seattle; 1993.
2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle
disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders:
Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.
Acer Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and
uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of
1995. All statements, other than statements of historical facts, included in this press release regarding
strategy, future operations, timelines, future financial position, future revenues, projected expenses,
regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of
management are forward-looking statements. Examples of such statements include, but are not
limited to, statements relating to the potential for our product candidates to safely and effectively
treat diseases and to be approved for marketing; the commercial or market opportunity of any of our
product candidates in any target indication and any territory; our ability to secure the additional capital
necessary to fund our various product candidate development programs; the adequacy of our capital
to support our future operations and our ability to successfully fund, initiate and complete clinical trials
and regulatory submissions; the ability to protect our intellectual property rights; our strategy and
business focus; and the development, expected timeline and commercial potential of any of our
product candidates. We may not actually achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in the forward-looking statements and you should not place
undue reliance on these forward-looking statements. Such statements are based on management’s
Ad hoc announcement pursuant to Art. 53 LR
current expectations and involve risks and uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements as a result of many factors,
including, without limitation, risks and uncertainties associated with the ability to project future cash
utilization and reserves needed for contingent future liabilities and business operations, the availability
of sufficient resources to fund our various product candidate development programs and to meet our
business objectives and operational requirements, the fact that the results of earlier studies and trials
may not be predictive of future clinical trial results, the protection and market exclusivity provided by
our intellectual property, risks related to the drug development and the regulatory approval process,
including the timing and requirements of regulatory actions, and the impact of competitive products
and technological changes. We disclaim any intent or obligation to update these forward-looking
statements to reflect events or circumstances that exist after the date on which they were made. You
should review additional disclosures we make in our filings with the Securities and Exchange
Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You
may access these documents for no charge at http://www.sec.gov.
Relief Forward-Looking Statements
This communication expressly or implicitly contains certain forward-looking statements concerning
RELIEF THERAPEUTICS Holding SA and its businesses. Such statements involve certain known and
unknown risks, uncertainties and other factors, including (i) whether the FDA will approve Acer’s NDA
for ACER-001, (ii) whether Relief will be able to submit an application for approval of ACER-001 in
Europe in Q2/Q3 2022 (or at all), (iii) whether any such application submitted to European authorities
seeking marketing authorization for ACER-001 for the treatment of patient in Europe with UCDs will be
approved, (iv) whether RLF-100 (aviptadil) will receive emergency use authorization in the United
States, (v) whether RLF-100 (aviptadil) will ever be submitted for authorization in Europe, (vi) whether
Relief’s ongoing disputes with its U.S. collaboration partner for RLF-100 (aviptadil) can be resolved
amicably, and (vii) those other risks, uncertainties and factors described in Relief’s annual and periodic
filings with the SIX Stock Exchange, all of which could cause the actual results, financial condition,
performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any
future results, performance or achievements expressed or implied by such forward-looking
statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does
not undertake to update any forward-looking statements contained herein as a result of new
information, future events or otherwise.
CORPORATE CONTACTS
Acer Therapeutics:
Jim DeNike
Acer Therapeutics Inc.
jdenike@acertx.com
+1 844-902-6100
RELIEF THERAPEUTICS Holding SA:
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
INVESTOR RELATIONS CONTACTS
Acer Therapeutics:
Hans Vitzthum
RELIEF THERAPEUTICS Holding SA:
Michael Miller
Ad hoc announcement pursuant to Art. 53 LR
LifeSci Advisors
hans@lifesciadvisors.com
+1 617-430-7578
Rx Communications Group
mmiller@rxir.com
+1-917-633-6086
# # #
Acer Therapeutics zieht an nur Relief nicht :-(
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es klappt bis dahin ! Allen noch einen schönen Abend !! :-)
Achtung!
Black Rock, Herculis Partners, Vanguard, State Street, Credit Suisse, UBS, GEM, Nuveen, DWS Intl... und jetzt ist der schöne State of Florida's Teacher Retirement and Government Pension Plan (bekannt als "Florida State Board of Administration") der neueste Ehrengast, der in den 700k -1M+ Club für RLFTF Institutional Investors aufgenommen wurde!!! Das ist richtig, wenn Sie einen staatlichen Pensionsplan, einen Lehrer-Pensionsplan oder einen Rentenplan in FL haben, herzlichen Glückwunsch
denn Ihre Rente wird bald viel sonniger aussehen 😉 . Ich glaube, dies war Teil einer Privatplatzierung Anfang des Jahres, aber ich konnte es erst jetzt bestätigen.
Und wer hat gesagt, dass wir keine Investmentfonds, Hedgefonds und Großbanken haben, die in uns investieren? Ich dachte, ich hätte das irgendwo gesehen 🤔 🧐!?! Wie auch immer, UBS, Credit Suisse und Vanguard sind da anderer Meinung! Ganz zu schweigen von all den anderen, die oben aufgeführt sind! Ich wollte Ihnen das nur mitteilen, weil ich diese Woche noch auf ein letztes Telefonat warte, bevor ich das Video veröffentliche. Aber glauben Sie mir, dieses Video wird es wert sein, und wenn alles nach Plan läuft, werden Sie überrascht sein, was Sie erwartet! GLTA!
Übersetzt mit www.DeepL.com/Translator (kostenlose Version)
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Ad hoc announcement pursuant to Art. 53 LR
Relief Therapeutics Announces Filing of Lawsuit Against its U.S. Collaboration
Partner, NeuroRx, Inc. and its CEO, Dr. Jonathan Javitt, for RLF-100™ (Aviptadil)
• Lawsuit alleges multiple breaches of Collaboration Agreement
Geneva, Switzerland, October 7, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”), today announced that it has filed a lawsuit against NeuroRx, Inc. and its Chief Executive Officer,
Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement between Relief and NeuroRx
relating to the development and commercialization of RLF-100™ (aviptadil). The complaint was filed in
the Supreme Court of the State of New York in Manhattan.
The complaint alleges that the defendants are in breach of numerous provisions of the Collaboration
Agreement, including without limitation (i) by failing to provide Relief with the full data set from NeuroRx's
recently completed phase 2b/3 clinical trial evaluating IV RLF-100™ (aviptadil) for the treatment of acute
respiratory failure due to COVID-19, which data and information are required to be provided to Relief by
NeuroRx under the Collaboration Agreement and which data and information are required for Relief to
seek approval to commercialize the product in Europe, (ii) by failing to allow Relief, despite multiple
requests, to conduct a forensic audit of NeuroRx's books and records to determine how the funds that
Relief provided to NeuroRx were actually used, (iii) by entering into multiple agreements relating to the
development of the product subject to the collaboration without Relief's consent, as required under the
Collaboration Agreement, (iv) by engaging in commercialization efforts in territories outside the purview
of NeuroRx's territory under the Collaboration Agreement, and (v) by developing additional COVID-19
treatments in violation of the exclusivity provisions of the Collaboration Agreement. The suit also alleges,
among other matters, breaches of the covenant of good faith and fair dealing and tortious interference
with prospective economic advantage. The Complaint, among other remedies, seeks damages, an order
compelling defendants to comply with multiple provisions of the Collaboration Agreement, and a
declaration directing NeuroRx to deliver the entire data set from the Phase 2b/3 clinical trial of
intravenously-administering aviptadil to Relief.
"We are disappointed that NeuroRx has continued to refuse to ameliorate their breaches of the
Collaboration Agreement," stated Jack Weinstein, Chief Financial Officer and Treasurer of Relief. "While
we continue to hope to settle these matters with NeuroRx, we are compelled to bring this action to
preserve our rights under the Collaboration Agreement and to allow us to continue to develop RLF-100™
(aviptadil) in a timely manner for the treatment of acute respiratory failure due to COVID-19 in our
territories."
Relief Therapeutics kündigt die Einreichung einer Klage gegen seinen US-Kooperationspartner
Partner NeuroRx, Inc. und dessen CEO, Dr. Jonathan Javitt, für RLF-100™ (Aviptadil)
- Klage erhebt den Vorwurf mehrerer Verstöße gegen die Kooperationsvereinbarung
Genf, Schweiz, 7. Oktober 2021 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
("Relief") gab heute bekannt, dass es eine Klage gegen NeuroRx, Inc. und dessen Chief Executive Officer eingereicht hat,
Dr. Jonathan Javitt, wegen mehrfacher Verstöße gegen die Kooperationsvereinbarung zwischen Relief und NeuroRx
in Bezug auf die Entwicklung und Kommerzialisierung von RLF-100™ (Aviptadil). Die Klage wurde eingereicht beim
Supreme Court of the State of New York in Manhattan eingereicht.
In der Klage wird behauptet, dass die Beklagten gegen zahlreiche Bestimmungen der Kooperationsvereinbarung verstoßen haben.
Kooperationsvereinbarung verstoßen haben, insbesondere (i) indem sie Relief nicht den vollständigen Datensatz der kürzlich abgeschlossenen klinischen Studie der Phase 2b/3 von NeuroRx zur Verfügung gestellt haben.
der kürzlich abgeschlossenen klinischen Phase 2b/3-Studie von NeuroRx zur Bewertung von IV RLF-100™ (Aviptadil) für die Behandlung von akutem
Behandlung von akutem Atemversagen aufgrund von COVID-19, welche Daten und Informationen Relief von
NeuroRx im Rahmen des Kooperationsvertrags zur Verfügung zu stellen sind und welche Daten und Informationen Relief benötigt, um
Genehmigung für die Vermarktung des Produkts in Europa zu beantragen, (ii) indem sie Relief trotz mehrfacher Aufforderung nicht die
eine forensische Prüfung der Bücher und Aufzeichnungen von NeuroRx durchzuführen, um festzustellen, wie die Gelder, die
Gelder, die Relief NeuroRx zur Verfügung gestellt hat, tatsächlich verwendet wurden, (iii) durch den Abschluss mehrerer Vereinbarungen in Bezug auf die
Entwicklung des Produkts, das Gegenstand der Zusammenarbeit ist, ohne die Zustimmung von Relief, wie in der
(iv) durch die Aufnahme von Vermarktungsbemühungen in Gebieten außerhalb des Geltungsbereichs
NeuroRxs Territorium gemäß der Kooperationsvereinbarung, und (v) durch die Entwicklung zusätzlicher COVID-19
Behandlungen unter Verstoß gegen die Exklusivitätsbestimmungen des Kooperationsvertrags. In der Klage wird außerdem behauptet,
unter anderem Verstöße gegen den Grundsatz von Treu und Glauben und die unerlaubte Beeinträchtigung
eines zukünftigen wirtschaftlichen Vorteils. In der Klage werden unter anderem Schadensersatz, eine Anordnung
die Beklagten zu verpflichten, mehrere Bestimmungen der Kooperationsvereinbarung einzuhalten, sowie eine
und eine Erklärung, die NeuroRx anweist, den gesamten Datensatz aus der klinischen Studie der Phase 2b/3 zu liefern
intravenös verabreichtem Aviptadil an Relief zu liefern.
"Wir sind enttäuscht, dass NeuroRx sich weiterhin weigert, seine Verstöße gegen die Kooperationsvereinbarung zu beheben.
Kollaborationsvereinbarung zu verbessern", sagte Jack Weinstein, Chief Financial Officer und Schatzmeister von Relief. "Während
wir weiterhin hoffen, diese Angelegenheiten mit NeuroRx zu regeln, sind wir gezwungen, diese Klage zu erheben, um unsere Rechte
um unsere Rechte im Rahmen der Kooperationsvereinbarung zu wahren und um die Entwicklung von RLF-100™ (Aviptadil)
(Aviptadil) für die Behandlung von akutem Atemversagen aufgrund von COVID-19 in unseren
Territorien."
Übersetzt mit www.DeepL.com/Translator (kostenlose Version)
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Ad hoc announcement pursuant to Art. 53 LR
Acer Therapeutics Receives Notice of Allowance of Key U.S. Patent Application Covering ACER-001
Formulation
Notice of allowance of ACER-001 formulation composition of matter patent application strengthens
proprietary position in U.S. until 2036
NEWTON, MA and GENEVA, SWITZERLAND – October 7, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER)
(“Acer”) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”), today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for Acer’s patent application No. 17/196,416 for certain claims related to ACER-001 (sodium
phenylbutyrate). The allowed patent claims in the application titled, “Palatable Compositions Including
Sodium Phenylbutyrate and Uses Thereof,” include pharmaceutical composition claims covering ACER-
001’s taste-masked, multi-particulate dosage formulation for oral administration.
The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon
completion of any outstanding administrative requirements. Acer’s patent is expected to be issued in
the fourth quarter of 2021 and expire in 2036. If it receives marketing approval for ACER-001, Acer
intends to submit the patent for listing by the U.S. Food and Drug Administration (FDA) in its Approved
Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
“We are extremely pleased to have received this Notice of Allowance from the USPTO for our
proprietary formulation of ACER-001 as we continue to advance its development to potentially treat
patients with Urea Cycle Disorders (UCDs), Maple Syrup Urine Disease (MSUD) and other possible
indications,” said Jeff Davis, Chief Business Officer at Acer. “This Notice marks another important
milestone in our pursuit of possible ACER-001 commercialization while we prepare to bring this
treatment to UCDs patients, subject to FDA’s approval of our ACER-001 New Drug Application.”
Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “In parallel to the patent
application efforts in the U.S., Acer and Relief are pursuing similar claims in the European Patent Office
to cover ACER-001 as we continue to execute on our plan to submit a Marketing Authorization
Application for ACER-001 for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”
Parties interested in the ACER-001 program for UCDs may sign up for updates at:
https://www.acertx.com/rare-disease-research/...cycle-disorders-ucds/
ACER-001 is an investigational product candidate which has not been approved by FDA, the European
Medicines Agency (EMA), or any other regulatory authority. There can be no assurance that this
product candidate will receive regulatory authority approval for marketing in any territory or become
commercially available for the indications under investigation.
Ad hoc announcement pursuant to Art. 53 LR
About UCDs
UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six
enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the
bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy,
somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches,
confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common
symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric
symptoms.1,2 The current treatment of patients with UCDs consists of dietary management to limit
ammonia production in conjunction with medications that provide alternative pathways for the
removal of ammonia from the bloodstream. Some patients may also require individual branched-chain
amino acid supplementation.
Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and
BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium
phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular
Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be
effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with
treatment is common. Reasons referenced for non-compliance associated with some available
medications include unpleasant taste, frequency with which medication must be taken, required
number of pills, and the high cost of the medication.3
About ACER-001
ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of
metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use
as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of
carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid
synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration
consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the
bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH of the
stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date
of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug
designation by the FDA for this indication. ACER-001 is an investigational product candidate which has
not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.
About Acer Therapeutics Inc.
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of
therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s
pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn
errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD);
ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for
treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen
(COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious
diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively
de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data,
mechanistic differentiation and/or accelerated paths for development through specific programs and
procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License
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Ad hoc announcement pursuant to Art. 53 LR
1
Relief Reports that its U.S. Collaboration Partner has Announced Progress on
Worldwide Commercial Scale Development of ZYESAMI™ (aviptadil)
Geneva, Switzerland, October 13, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious
diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner,
NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing they have
submitted a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) to
the U.S. Food and Drug Administration (FDA), containing documentation that confirmed Nephron
Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. According to the press
release, NRx has also received notification that a European QP (Qualified Person) Auditor has completed
an inspection at a separate manufacturing facility with no adverse findings. The related NRx press release
can be accessed through the following link.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100™
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed
and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
Ad hoc announcement pursuant to Art. 53 LR
2
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its
litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil
will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients
with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and
filings with the SIX, which could cause the actual results, financial condition, performance or achievements
of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding
SA is providing this communication as of this date and do not undertake to update any forward-looking
statements contained herein as a result of new information, future events or otherwise.
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kurzen Unterbrechungen wie gestern, nur eine Richtung. Bei der Anzahl verhältnismaßig guter
News müsste doch die Aktie mindestens bei 0,20 bis 0,25 stehen, oder übersehe ich etwas?
Grüße vom frustrierten Hobbyaktionär
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Anyway, if you watch my video I recorded sometime in July, you will notice I said I absolutely hate making predictions regarding EUA. Part of that reason is because I was afraid this was going to come down to a manufacturing/ processing issue. Unfortunately, it has. This is my opinion, but the timeline matches perfectly. I'll go over it in my video. Basically, I said nothing would happen regarding EUA until after first week in August.
After first week in August, (08/09/21) is when we started seeing some action..... specifically regarding the FDA asking for more info and the USPTO statement of use being published as "under examination" along with published pictures of ZYESAMI (tm) AVIPTADIL. Here's the rub...I was curious if Dr. J was going to go forward with his thinking because he also attached RLF-100(002) as part of the labeling, which necessarily gives a tip of the hat to RLF100 being the prior art !!!🤔 This helps immensely on the scale of "obviousness" , plus in combination with the CA. Some of those are legal terms that u will get into this weekend, but I'm putting it out there now in case you want to research.
A couple of other things I've noticed along the way is that some of confusing CDER and CBER rules. In my opinion, Aviptadil falls under the small molecules, and therefore "CDER" , regulations. These are specialized subdivisions of the FDA. Aviptadil acetate is what ZYESAMI was touted as in former filings by NRXP. In other words, acetate denotes a necessary buffer! If those on YB remember, I discussed about acetic acid and its use regarding the inhaled form being a hinging issue as well. But, I'll tie everything together this weekend. Sorry for the delay and GLTA!
I know I've been more silent than usual lately, especially considering the recent material events. I WILL release a video this weekend. I've gotten the information I was waiting for, so my apologies for the delay. And, don't fret too much with the posturing going on. This is an alpha male gorilla chest-beating battle at the moment. If you get too emotionally evolved, you will get lost in the Fray (which is also a great throwback music group by the way ...not as good as Coldplay of course, but who is?)
Anyway, if you watch my video I recorded sometime in July, you will notice I said I absolutely hate making predictions regarding EUA. Part of that reason is because I was afraid this was going to come down to a manufacturing/ processing issue. Unfortunately, it has. This is my opinion, but the timeline matches perfectly. I'll go over it in my video. Basically, I said nothing would happen regarding EUA until after first week in August.
After first week in August, (08/09/21) is when we started seeing some action..... specifically regarding the FDA asking for more info and the USPTO statement of use being published as "under examination" along with published pictures of ZYESAMI (tm) AVIPTADIL. Here's the rub...I was curious if Dr. J was going to go forward with his thinking because he also attached RLF-100(002) as part of the labeling, which necessarily gives a tip of the hat to RLF100 being the prior art !!!🤔 This helps immensely on the scale of "obviousness" , plus in combination with the CA. Some of those are legal terms that u will get into this weekend, but I'm putting it out there now in case you want to research.
A couple of other things I've noticed along the way is that some of confusing CDER and CBER rules. In my opinion, Aviptadil falls under the small molecules, and therefore "CDER" , regulations. These are specialized subdivisions of the FDA. Aviptadil acetate is what ZYESAMI was touted as in former filings by NRXP. In other words, acetate denotes a necessary buffer! If those on YB remember, I discussed about acetic acid and its use regarding the inhaled form being a hinging issue as well. But, I'll tie everything together this weekend. Sorry for the delay and GLTA!
I know I've been more silent than usual lately, especially considering the recent material events. I WILL release a video this weekend. I've gotten the information I was waiting for, so my apologies for the delay. And, don't fret too much with the posturing going on. This is an alpha male gorilla chest-beating battle at the moment. If you get too emotionally evolved, you will get lost in the Fray (which is also a great throwback music group by the way ...not as good as Coldplay of course, but who is?)
Anyway, if you watch my video I recorded sometime in July, you will notice I said I absolutely hate making predictions regarding EUA. Part of that reason is because I was afraid this was going to come down to a manufacturing/ processing issue. Unfortunately, it has. This is my opinion, but the timeline matches perfectly. I'll go over it in my video. Basically, I said nothing would happen regarding EUA until after first week in August.
After first week in August, (08/09/21) is when we started seeing some action..... specifically regarding the FDA asking for more info and the USPTO statement of use being published as "under examination" along with published pictures of ZYESAMI (tm) AVIPTADIL. Here's the rub...I was curious if Dr. J was going to go forward with his thinking because he also attached RLF-100(002) as part of the labeling, which necessarily gives a tip of the hat to RLF100 being the prior art !!!🤔 This helps immensely on the scale of "obviousness" , plus in combination with the CA. Some of those are legal terms that u will get into this weekend, but I'm putting it out there now in case you want to research.
A couple of other things I've noticed along the way is that some of confusing CDER and CBER rules. In my opinion, Aviptadil falls under the small molecules, and therefore "CDER" , regulations. These are specialized subdivisions of the FDA. Aviptadil acetate is what ZYESAMI was touted as in former filings by NRXP. In other words, acetate denotes a necessary buffer! If those on YB remember, I discussed about acetic acid and its use regarding the inhaled form being a hinging issue as well. But, I'll tie everything together this weekend. Sorry for the delay and GLTA!
Ich weiß, ich war in letzter Zeit stiller als sonst, vor allem in Anbetracht der jüngsten materiellen Ereignisse. Ich WERDE dieses Wochenende ein Video veröffentlichen. Ich habe die Informationen erhalten, auf die ich gewartet habe, also entschuldige ich mich für die Verzögerung. Und machen Sie sich nicht zu viele Gedanken über das Getue, das hier stattfindet. Dies ist im Moment ein Kampf zwischen Alphamännchen und Gorillas, die auf die Brust schlagen. Wenn du dich zu sehr emotional entwickelst, verlierst du dich in The Fray (die übrigens auch eine großartige Throwback-Musikgruppe sind ... natürlich nicht so gut wie Coldplay, aber wer ist das schon?)
Wie dem auch sei, wenn Sie sich mein Video ansehen, das ich irgendwann im Juli aufgenommen habe, werden Sie feststellen, dass ich es absolut hasse, Vorhersagen zur EUA zu machen. Das liegt unter anderem daran, dass ich befürchtete, dass es sich um ein Herstellungs-/Verarbeitungsproblem handeln würde. Leider ist das der Fall. Dies ist meine Meinung, aber der Zeitplan passt perfekt. Ich werde in meinem Video darauf eingehen. Im Grunde habe ich gesagt, dass in Bezug auf EUA bis nach der ersten Augustwoche nichts passieren würde.
Nach der ersten Augustwoche (21.09.08) begann die Aktion....., insbesondere in Bezug auf die FDA, die um weitere Informationen bat, und die USPTO-Verwendungserklärung, die als "in Prüfung" zusammen mit veröffentlichten Bildern von ZYESAMI (tm) AVIPTADIL veröffentlicht wurde. Hier ist der Knackpunkt... Ich war neugierig, ob Dr. J mit seinen Überlegungen weitermachen würde, weil er auch RLF-100(002) als Teil der Beschriftung beigefügt hat, was zwangsläufig einen Hinweis darauf gibt, dass RLF100 der Stand der Technik ist!!! 🤔 Dies hilft immens auf der Skala der "Offensichtlichkeit", plus in Kombination mit dem CA. Einige davon sind juristische Begriffe, mit denen wir uns an diesem Wochenende beschäftigen werden, aber ich stelle sie jetzt zur Verfügung, falls Sie recherchieren wollen.
Ein paar andere Dinge, die mir auf dem Weg aufgefallen sind, sind die verwirrenden Regeln von CDER und CBER. Meiner Meinung nach fällt Aviptadil unter die Vorschriften für kleine Moleküle und damit unter die "CDER"-Vorschriften. Dies sind spezielle Unterabteilungen der FDA. Aviptadil-Acetat ist das, als das ZYESAMI in früheren Anträgen von NRXP angepriesen wurde. Mit anderen Worten, Acetat bezeichnet einen notwendigen Puffer! Wenn sich die YB-Mitglieder erinnern, habe ich über Essigsäure und ihre Verwendung in Bezug auf die inhalative Form diskutiert, die ebenfalls eine Rolle spielt. Aber ich werde alles an diesem Wochenende zusammenfassen. Entschuldigung für die Verspätung und GLTA!
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positiven Bereich werden nicht honoriert oder führten sogar zu Kursrücksetzern .
Viele vermuten eine gesteuerte Manipulation . Hier mal ein Link zum Lab-Bericht der
Relief bei 0,76 Rappen sieht . Allerdings vom 26.07.21 .
https://www.valuationlab.com/app/download/...26JUL21.pdf?t=1630341865
Durch das ganze Gezanke mit Javitt wegen Patente usw. verschärft sich die ganze Sache
noch und macht es nicht einfacher . Bin aber immer noch zu 100% von überzeugt das
Relief auf einem guten Weg ist und auch ausserhalb von Covid mit Aviptadil und der
Produktpalette von APR und Acer auf gutem Weg ist . Wegen der Patente mache ich mir
auch nicht die grössten Sorgen . Advita gehört ebenfalls zu Relief und besitzt die erforderlichen
Patente für die Inhaler - Studie mit Aviptadil ! Es bleibt spannend :-)
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damals gewundert warum Relief die Advita übernommen hat . :-)
https://l.facebook.com/...n9FWHGTeXGqr25BFG13BuHV3Mfof4KX5Il1Ctk0Fmcb
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Ad hoc announcement pursuant to Art. 53 LR
1
Relief Reports that its U.S. Collaboration Partner has Announced that the Journal
of Infectious Diseases and Treatment has Published Positive Trial Data of
Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with
Respiratory Failure
Geneva, Switzerland, October 15, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
(“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious
diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner,
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has issued a press release announcing that the peer-
reviewed Journal of Infectious Diseases and Treatment has published positive trial data from a
prospective, open label, administratively controlled trial of aviptadil in high comorbidity patients suffering
from critical COVID-19 with respiratory failure. According to the press release, the study reported 60-day
survival in 81% of those treated with aviptadil, compared to 21% survival among those who received
standard of care treatment at the Houston Methodist Hospital (P<.0001). The press release also reports
that a similar 9-fold advantage was seen in the cumulative probability of recovery from respiratory failure
(P<.0001). The related NRx press release can be accessed through the following link.
ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing
and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™
(aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S.
for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the
worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate
release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle
Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR
Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed
and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.
Follow us on LinkedIn.
Ad hoc announcement pursuant to Art. 53 LR
2
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements
concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks,
uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its
litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil
will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients
with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and
filings with the SIX, which could cause the actual results, financial condition, performance or achievements
of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding
SA is providing this communication as of this date and does not undertake to update any forward-looking
statements contained herein as a result of new information, future events or otherwise.
Ad-hoc-Mitteilung gemäss Art. 53 LR
1
Relief meldet, dass sein amerikanischer Kooperationspartner bekannt gegeben hat, dass das Journal
of Infectious Diseases and Treatment positive Studiendaten von Aviptadil bei
Aviptadil bei Patienten mit hoher Komorbidität, die an kritischer COVID-19 mit
Versagen der Atemwege
Genf, Schweiz, 15. Oktober 2021 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF)
("Relief"), ein biopharmazeutisches Unternehmen mit dem Ziel, Patienten therapeutische Hilfe bei schweren
Krankheiten mit hohem ungedecktem Bedarf zu lindern, gab heute bekannt, dass die Muttergesellschaft seines US-Kooperationspartners,
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx"), eine Pressemitteilung herausgegeben hat, in der bekannt gegeben wird, dass die Fachzeitschrift
Journal of Infectious Diseases and Treatment positive Studiendaten aus einer prospektiven, offenen
einer prospektiven, offenen, administrativ kontrollierten Studie mit Aviptadil bei Patienten mit hoher Komorbidität
kritischen COVID-19 mit Atemstillstand leiden. In der Pressemitteilung heißt es, dass in der Studie die 60-Tage
81 % der mit Aviptadil behandelten Patienten überlebten, verglichen mit 21 % bei den Patienten, die
der Standardbehandlung im Houston Methodist Hospital (P<.0001). In der Pressemitteilung heißt es außerdem
dass ein ähnlicher 9-facher Vorteil bei der kumulativen Wahrscheinlichkeit einer Erholung vom Atemversagen festgestellt wurde
(P<.0001). Die entsprechende NRx-Pressemitteilung kann über den folgenden Link aufgerufen werden.
ÜBER RELIEF
Relief konzentriert sich in erster Linie auf Programme im klinischen Stadium, die auf Molekülen basieren, die in der Vergangenheit bereits klinisch getestet
klinischen Erprobung und Anwendung bei menschlichen Patienten oder einer starken wissenschaftlichen Grundlage. Der führende Arzneimittelkandidat von Relief, RLF-100™
(Aviptadil), eine synthetische Form des vasoaktiven intestinalen Peptids (VIP), befindet sich in den USA in der späten Phase der klinischen Prüfung.
für die Behandlung von Atemschwäche aufgrund von COVID-19. Als Teil seiner Strategie zur Diversifizierung der Pipeline,
schloss Relief im März 2021 eine Kooperations- und Lizenzvereinbarung mit Acer Therapeutics für die
weltweite Entwicklung und Vermarktung von ACER-001. ACER-001 ist eine geschmacksmaskierte und sofort
Pulverformulierung von Natriumphenylbutyrat (NaPB) für die Behandlung von Harnstoffzyklusstörungen
Störungen des Harnstoffzyklus und der Ahornsirup-Urin-Krankheit. Darüber hinaus haben Reliefs kürzlich abgeschlossene Übernahmen von APR
Applied Pharma Research SA und AdVita Lifescience GmbH, bringt Relief eine vielfältige Pipeline von vermarkteten
und Programmen im Entwicklungsstadium.
RELIEF THERAPEUTICS Holding SA ist an der SIX Swiss Exchange unter dem Symbol RLF notiert und in den
OTCQB in den USA unter dem Symbol RLFTF notiert. Weitere Informationen finden Sie unter www.relieftherapeutics.com.
Folgen Sie uns auf LinkedIn.
Ad-hoc-Mitteilung gemäss Art. 53 KR
2
KONTAKT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Finanzvorstand und Schatzmeister
contact@relieftherapeutics.com
FÜR MEDIEN-/INVESTORENANFRAGEN:
Rx-Kommunikationsgruppe
Michael Müller
+1-917-633-6086
mmiller@rxir.com
Haftungsausschluss: Diese Mitteilung enthält ausdrücklich oder stillschweigend bestimmte zukunftsgerichtete Aussagen
über RELIEF THERAPEUTICS Holding SA. Solche Aussagen beinhalten bestimmte bekannte und unbekannte Risiken,
Ungewissheiten und andere Faktoren, einschließlich (i) ob RELIEF THERAPEUTICS Holding SA in seinem
Rechtsstreit gegen NeuroRx über die Bedingungen des Kooperationsvertrags durchsetzen wird, (ii) ob Aviptadil
Aviptadil jemals in den USA, in Großbritannien oder in der EU für die Behandlung von Atemversagen bei Patienten
Patienten mit COVID-19 zugelassen wird, und (iii) die Risiken, die in den Pressemitteilungen von RELIEF THERAPEUTICS Holding SA und den
der SIX beschriebenen Risiken, die dazu führen könnten, dass die tatsächlichen Ergebnisse, die Finanzlage, die Leistung oder der Erfolg von
der RELIEF THERAPEUTICS Holding SA wesentlich von den in den zukunftsgerichteten Mitteilungen und Einreichungen der RELIEF THERAPEUTICS Holding SA
Ergebnissen, Leistungen oder Errungenschaften abweichen, die in solchen zukunftsgerichteten Aussagen ausgedrückt oder impliziert werden. RELIEF THERAPEUTICS Holding
SA stellt diese Mitteilung zu diesem Datum zur Verfügung und verpflichtet sich nicht, die hierin enthaltenen zukunftsgerichteten
aufgrund neuer Informationen, zukünftiger Ereignisse oder aus anderen Gründen zu aktualisieren.
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