Phase III trial of FMX 101 meets endpoints in acne.- Foamix Pharma.

Foamix Pharmaceuticals announced the topline results of its third Phase III clinical trial (FX2017-22) of FMX 101 (4% minocycline foam) 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 mean inflammatory lesion count at baseline was 30.7 and 30.8 for the FMX101 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 (�moderate�) or 4 (�severe�) was 84.0% and 16.0%, respectively, in the FMX101 treatment group and 83.5% and 16.5%, respectively, in the vehicle treatment group. The safety profile of FMX 101 was found to be consistent with that determined from the two prior Phase III studies (FX2014-04 and FX2014-05).

The most commonly reported adverse event in the study was (viral) upper respiratory tract infection (6.4% in both FMX101 and vehicle treatment groups). There were no treatment-related serious adverse events. A total of 5 subjects discontinued the study due to an adverse event (3 in the FMX101 treatment group and 2 in the vehicle treatment group). FMX101 appeared to be generally safe and well-tolerated. Foamix plans to continue to share data from this study as they become available over the remainder of 2018.