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3 high-ranking companies on the diabetes market to watch in 2017
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Whereas DexCom is trying to replace the fingerstick test side of the equation, Oramed is trying to replace the injectable administration element of diabetes self-care. The company has developed a drug called ORMD-0801 – an oral insulin pill. Oral insulin has long been the holy grail of the diabetes space. However, up until now, the successful development of an oral insulin asset has been a pretty much insurmountable task. The difficulty is rooted in bioavailability. Insulin is a very fragile peptide. When exposed to the gastrointestinal microenvironment (gut, liver, stomach etc.) it very quickly breaks down and – in turn – becomes ineffective. This is why current standard of care dictates insulin must be injected into the bloodstream subcutaneously. Direct access mitigates the degradatory impact the body has on the peptide, and – in turn – maximizes its efficacy in reducing blood glucose levels. A number of companies have attempted to package insulin in various forms, but all have been unsuccessful in being able to demonstrate a comparative clinical benefit to the current injectable standard of care when subject to clinical evaluation. That is, all except ORMD-0801. Oramed has collected swathes of clinical data suggesting it’s oral insulin candidate is at least as effective as injectable insulin in lowering blood glucose levels, the latest of which came about as a result of a phase IIb study, with top line initially reported in May last year. This study showed a statistically significant decrease in the primary endpoint, pooled night-time glucose mean percentage change, of 6.47% from run-in, between placebo and active cohorts (p=0.0268). Additionally, the study demonstrated a solid safety profile for the drug, with no drug-related serious adverse events.
The final phase of clinical testing, a phase 3 study, was – at the time – reported as set to begin during late 2016 or early 2017. With the former bracket now passed, the assumption is that a pivotal trial should begin sometime this quarter. We expect the initiation of a pivotal oral insulin trial (one that will put Oramed at the front of the pack from a global oral insulin development perspective) to generate a large amount of speculative investor attention for the company. By proxy, we expect this attention will serve to underpin an upside revaluation in Oramed’s market capitalization as the year matures and the trial gets under way.
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http://born2invest.com/articles/...-diabetes-market-to-watch-in-2017/
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