Shares of Foamix Pharmaceuticals (FOMX) are trading higher after the company announced top line results for its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne.
The study met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment (IGA) treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline. The safety profile of FMX101 was found to be consistent with that determined from the two prior Phase 3 studies (FX2014-04 and FX2014-05).
David Domzalski, CEO of Foamix: "This is the most significant milestone to date for Foamix and brings us closer to helping patients who struggle with the physical and psycho-social effects of acne. If approved, we believe FMX101 would be the first topical minocycline product available for patients in the United States."
Foamix hopes to file a New Drug Application (NDA) with the FDA by year end.
Management sees a significant unmet need in the large acne market. There are 5 million prescriptions written for the indication annually (4 million of which are topical).
The company has yet to decide on pricing but management did say they want to maximize patient access. Pricing would be closer to topical acne medications rather than more expensive oral treatments.
In March of 2017, the stock fell some 50% after one of the prior Phase 3 trials for the drug missed the Investigator's Global Assessment (IGA) co-primary end point.
The acne indication has been notoriously difficult in recent years as promising treatments inevitably failed in clinical trials.
Foamix results were positive, but it seems some skeptics remain.
The stock quickly gave up much of its gains this morning.
Foamix also expects to report top line results for two Phase 3 clinical studies evaluating FMX103, topical minocycline foam 1.5%, for the treatment of papulopustular rosacea early in the fourth quarter.
The company's current market capitalization is ~$250 mln, giving the company an enterprise value just under $200 mln excluding $56 mln in liquid assets.