Foamix Pharmaceuticals Announces Additional Phase 3 Trial for FMX101

Foamix Pharmaceuticals announced results from additional analysis of the recently completed Phase 3 pivotal trials for its lead candidate FMX101 in moderate to severe acne.

Foamix has reviewed its regulatory strategy for FMX101.  Based on the knowledge gained from the results of the first two pivotal trials (Trials 04 and 05), the company intends to conduct a third U.S. Phase 3 Trial, beginning mid-year, in patients with moderate to severe acne.  If the results will be positive, this trial is expected to form the basis for a New Drug Application (NDA) which the company plans to submit in the second half of 2018.

"The totality of the clinical efficacy results for FMX101, including the further analysis we conducted of the Phase 3 data, are positive.  Inconsistent results were noted in only one of the efficacy endpoints and the product appears to be safe and well tolerated," Dov Tamarkin, Ph.D., CEO of Foamix said. "Based on our analysis of the efficacy results from Trials 04 and 05, we plan to conduct a third trial to validate the results, with the same co-primary endpoints and enrollment criteria but with a substantially increased sample size.  We intend to begin enrolling patients in this third trial mid-year.  If approved, we believe FMX101 will be the first FDA-approved topical minocycline treatment for moderate-to-severe acne, a skin disorder that affects millions of people with potentially significant psychological and social implications."

Foamix previously announced topline data from two double-blind, randomized, placebo-controlled Phase 3 trials (Trials 04 and 05) that had investigated FMX101in a total of 961 patients with moderate-to-severe acne. Patients had been treated with either FMX101 (minocycline foam 4%) or vehicle foam once daily over 12 weeks. The results of the co-primary endpoints (absolute change in the number of inflammatory lesions and the proportion of patients achieving investigator global assessment (IGA) success at week 12) for trials 04 and 05 were presented separately.