Foamix Announces Additional Positive Topline Results from Third Phase 3 Trial Evaluating FMX101

Foamix Pharmaceuticals (NASDAQ:FOMX) a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced additional topline results from its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne.

As quoted in the press release:

As the company previously communicated, 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. Results from both co-primary endpoints demonstrated highly statistically significant results for FMX101 vs vehicle, with p-values <0.0001.  The safety profile of FMX101 was consistent with that determined from the two prior Phase 3 studies (FX2014-04 and FX2014-05). Additional study results and analysis are as follows:

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