Nice OM plug..
Top Contender: Innovation Pharmaceuticals (IPIX)
Dr. Sonis is not just lending his expertise to Enzychem, he has been working closely with Innovation Pharmaceuticals (IPIX) for years, officially taking the position as a Scientific Advisor in March 2016. Dr. Sonis has been assisting in the development of Innovation Pharma's Brilacidin-OM, an oral rinse version of the company's defensin-mimetic Brilacidin, a novel synthetic, non-peptidic small molecule shown to have a dynamic mechanism of action that demonstrates antibiotic, anti-inflammatory and immunomodulatory properties.
To that end, it's a perfect fit for OM, given that it is a condition of inflammation and infection occurring in a typically depressed immune system. IPIX (née Cellceutix Corp.) is developing Brilacidin-OM under an FDA Fast Track designation to attenuate OM in patients with head and neck cancer undergoing chemo-radiation. Incidentally, the company at one point approached the FDA about an Orphan Drug designation, which can provide certain benefits for treating rare diseases, but was informed by the agency that OM was not rare enough to qualify, an auspicious moment speaking to market size.
IPIX is ahead of Enzychem and most others, as a 61-patient Phase 2 study has been completed with topline data expected in the coming weeks, a milestone moment for the company. The primary endpoint is evaluating incidence of severe OM (WHO grade 3-4) during and at the end of seven weeks of therapy.
Take note that Innovation Pharma and Enzychem have primary endpoints of "incidence" of OM. This is an important distinction between those looking at "duration" as the primary endpoint because it means that the companies are trying to prevent severe OM in the first place, rather than just trying to moderate the time patients must deal with severe OM. Both companies are looking at duration as a secondary endpoints, which is obviously important, but the blockbuster potential resides in stopping the onset of severe OM, as well as ameliorating the condition swiftly should it develop.
That's not to say that others targeting severe OM aren't looking at incidence, but defining it as a primary endpoint sets the bar a little higher for difficulty in achieving study success and speaks to confidence in the drug.
Innovation Pharma is looking to build upon positive interim data in March that showed a marked reduction in incidence of severe OM in patients treated with Brilacidin who received at least 55 Gy cumulative units of radiation. Merely a sample of the overall study, only 2 of 9 (22.22%) patients receiving Brilacidin-OM therapy developed severe OM, compared to 7 out of 10 patients (70%) in the placebo group. Furthermore, a look at secondary endpoints showed that when severe OM developed, it didn't last as long for the two patients on Brilacidin-OM (mean = 10.5 days) versus those on placebo (mean = 14 days).
Brilacidin-OM was generally well tolerated with no drug-related adverse events reported.
The safety and efficacy data is anchored by several other clinical trials of Brilacidin in different formulations for different indications. As a single-dose intravenous antibiotic, the drug was shown to deliver comparable results to the seven-day regimen of the blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in a Phase 2b study. In a successfully completed Phase 2 proof-of-concept study earlier this year, the majority of patients treated with Brilacidin as an enema achieved clinical remission of ulcerative proctitis/ulcerative proctosigmoiditis, two forms of inflammatory bowel disease. Importantly, the UP/UPS study lends further validation to localized delivery of Brilacidin with minimal systemic exposure.
Looking ahead to the upcoming data set from the Phase 2 OM study, if such low incidence (22.22%) can be safely achieved, IPIX will be in an enviable position. As Dr. Sonis conveyed, a large percentage of head and neck cancer patients normally progress to severe OM even with today's preventative measures. Another important part of un-blinding the data will allow IPIX to glean important info on the drug's effect against certain types of tumors and therapies to determine parameters for a registration study if the data warrants. In any case, a substantial decrease in incidence and duration in severe OM for a rinse-and-spit drug delivery method puts IPIX amongst the leaders in the OM space, which is why investors will be watching closely for the data.
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