REHOVOT, Israel, and BRIDGEWATER, New Jersey, Nov. 28, 2016 /PRNewswire/ -- Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced that it has completed patient enrollment according to plan in the Company's two Phase 3 clinical trials to evaluate the efficacy and safety of FMX101, a topical 4% minocycline foam, in the treatment of moderate-to-severe acne. Foamix is conducting the two Phase 3 pivotal trials simultaneously, and expects to report top-line results in the first half of 2017.
"Completing enrollment of these Phase 3 clinical trials is an important milestone for our lead candidate, FMX101, as it moves us closer to providing an effective, convenient, first-in-class topical treatment for patients with moderate-to-severe acne," said Dr. Dov Tamarkin, Chief Executive Officer of Foamix. "I look forward to sharing the clinical trial results in the first half 2017. If approved, FMX101 is expected to be the first FDA-approved topical antibiotic treatment for moderate-to-severe acne, a skin disorder that affects millions of people every year with potentially significant psychological and social implications." About FMX101 Phase 3 Program The Phase 3 program consists of two multi-center trials, each with a target enrollment of 450 patients with moderate-to-severe acne. Patients were randomized on a 2:1 basis (active vs. vehicle), initially into a 12-week double-blind phase, where they are treated topically once daily with either FMX101 (4% minocycline foam) or the respective foam vehicle. The two co-primary efficacy endpoints of both trials are (1) the absolute change from baseline in inflammatory lesion counts in each treatment group at week 12; and (2) the proportion of patients achieving success at week 12 as defined by an Investigator's Global Assessment (IGA) score of "clear" or "almost clear" (score of 0 or 1) and at least a 2-grade improvement (decrease) from baseline at week 12. Safety evaluation will include reported adverse events, assessments of tolerability, clinical laboratory tests and vital signs.