Phase III studies of FMX 103 show improvement in rosacea.- Foamix Pharma.

Foamix Pharmaceuticals announced the topline results from its Phase III program evaluating FMX 103 (1.5% minocycline foam), in the treatment of moderate-to-severe papulopustular rosacea. Studies FX2016-11 and FX2016-12 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.

In study FX2016-11, the mean inflammatory lesion count at baseline was 28.5 and 29.0 for the FMX 103 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 (�moderate�) or 4 (�severe�) was 89.7% and 10.3%, respectively, in the FMX 103 treatment group and 86.7% and 13.3%, respectively, in the vehicle treatment group. In study FX2016-12, the mean inflammatory lesion count at baseline was 30.0 and 30.2 for the FMX 103 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 (�moderate�) or 4 (�severe�) was 86.2% and 13.8%, respectively, in the FMX 103 treatment group and 82.9% and 17.1%, respectively, in the vehicle treatment group.

FMX 103 demonstrated statistically significant improvement in subject disease severity when compared to vehicle foam. The safety profile of FMX 103 was found to be favorable. The most commonly reported adverse event in both studies was upper respiratory tract infection (FX2016-11: 0.8% in the FMX 103 treatment group and 2.0% in the vehicle treatment group. FX2016-12: 2.9% in the FMX 103 treatment group and 3.1% in the vehicle treatment group). There were no treatment-related serious adverse events. Data from study FX2016-13 evaluating the long-term safety of FMX 103 are expected to be reported in the first half of 2019.