A company openly announcing its anticipations without qualifiers is not something to be brushed over. We understand confidence behind closed doors, but why openly invite high expectations, especially when every word of every press release is combed over exhaustively?
The answer we got was fascinating. Besides the solid data from previous safety and efficacy trials, and what we know from Gilead and its own version of the same drug, we learned that for infectious disease drugs specifically, translation from murine (mouse) models to humans is much more assured. Why? Because in both cases with infectious disease, the same drug is killing the same pathogen directly, rather than relying on a mouse model that may resemble a disorder only symptomatically. Plus, a 28-day toxicology study on rats for encochleated amphotericin-B showed no signs of toxicity even with a 200-fold higher dose than intravenous. Strong evidence that the cochleates are shielding the body from the drug’s toxic side effects. The remaining question is, does the drug still work when encochleated?
Matinas BioPharma Holdings Inc (OTCMKTS:MTNB) thinks so, and felt comfortable publicly stating what it in fact anticipates, and that is a successful Phase IIa trial for MAT2203. Management did clarify, however, that the language of the press release, though carefully chosen, was not indicative of any actual data seen regarding the trial currently taking place. Only past data and extrapolation.
Amphotericin B’s toxicity notwithstanding, the reason it is the gold standard in candidiasis is that it is not metabolized in the liver, and therefore there are no drug-to-drug interactions. This is crucial because again, these infections happen most often in leukemia patients who are immunocompromised, and leukemia patients are on a lot of drugs already. Candida infections occur in 20% of these patients, and that’s why the Phase IIa is focusing on hereditary immunocompromised patients, then to be shifted to a prophylactic trial of 400-500 immunocompromised patients
After completion of this Phase IIa scheduled for the first-half of next year, the following Phase III intends to be a prophylactic study – an area that market leader Gilead has not ventured into. This in itself is noteworthy, because the thought of using such a toxic antifungal as a prophylactic was, until now, unthinkable. If the company can even get to actively planning the Phase III, which it will if this Phase IIa succeeds, it would mean that the cochleates are safe to the extent that the FDA is willing to allow a Phase III prophylactic trial using a drug that was been hitherto considered too toxic to even test in such a way.
The key then, is that the very fact that a Phase III trial would even be allowed with such a drug would itself prove that Matinas’ encochleates actually work, at least in terms of shielding the body from the toxic side effects of dangerous drugs, and that itself should be a huge value booster.
Bottom line with Matinas is this: if the Phase II succeeds by mid-2017, we’re looking at a drug that could displace Gilead Sciences, Inc. (NASDAQ:GILD)’s $350M AmBisome and eclipse it as a prophylactic, at least. This could conceivably expand its market over $350M because a prophylactic would be across the board.
Once Matinas BioPharma Holdings Inc (OTCMKTS:MTNB) has that foot in the door, it will continue encochleating more drugs, and it is already working on potential blockbusters including amikacin, another toxic anti-infective used as a last resort against hospital-borne superbugs. With finances sufficient to get it through this crucial Phase IIa and only a small sales force needed to actually market encochleated amphotericin B given the focused patient population, we see Matinas as a Big Pharma-independent firm and a rare low-risk, high-return stock, especially at a sub-$100M market cap.
Note: This article is written by David Rich and was originally published at Market Exclusive.
