Foamix begins Phase III program of FMX103 for rosacea

Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) began a Phase III program to evaluate FMX103 in patients with moderate to severe papulopustular rosacea. The program comprises a pair of double-blind, vehicle-controlled, U.S. trials in about 750 patients each to receive once-daily topical FMX103 for 12 weeks. Patients who complete the 12-week treatment period have the option to enroll in a 9-month, open-label safety extension study. Top-line data are expected in mid-2018.

The co-primary endpoints are the proportion of patients achieving success at week 12 based on Investigator's Global Assessment (IGA) score with success defined as a score of "clear" or "almost clear" and a ≥2-grade improvement from baseline, and change in inflammatory lesion count at week 12...