Foamix Pharmaceuticals has announced the topline results of its Phase 2 clinical trial of FMX103 for the treatment of papulopustular rosacea. Statistically significant differences were demonstrated for improvement in the primary and secondary efficacy endpoints (reduction in the number of inflammatory lesions and improvement of Investigator Global Assessment (IGA) score) for FMX103 compared with the vehicle-treated group.
The double-blind, placebo-controlled trial included 233 subjects with moderate to severe rosacea enrolled at 18 sites in Germany. Subjects were randomized to receive either one of two doses of FMX103 minocycline foam (3% or 1.5%) or vehicle foam once daily over 12 weeks, followed by a 4-week post-treatment evaluation. Efficacy endpoints were the absolute change in the number of inflammatory lesions (papules and pustules) and improvement of IGA of severity. Safety and tolerability were also evaluated.
The mean baseline lesion count for all groups ranged from 30.6 to 34.5 and IGA scores were all moderate (score 3) or severe (score 4), with about 50% to 60% of the subjects having a severe rating. At week 12, the 1.5% and 3% doses of FMX103 both significantly reduced the number of papules and pustules vs. vehicle. The mean reduction in lesion count of each treatment group vs. baseline was 21.1 for the 1.5% dose, 19.9 for the 3% dose and 7.8 for vehicle; the corresponding percent reductions were 61.4% and 55.5% for the FMX103 1.5% and 3% groups, respectively, and 29.7% for vehicle.
Both the 1.5% and 3% doses of FMX103 were significantly better compared to vehicle in reducing the IGA score by 2 grades and in reaching a “clear” (score 0) or “almost clear” (score 1) rating at week 12. Both doses were efficacious and well tolerated. There were no serious treatment-related adverse events (AEs).
“We are extremely encouraged that our Phase 2 dose-finding study demonstrated that FMX103 appears to be safe and effective in the treatment of moderate to severe papulopustular rosacea,” said Dov Tamarkin, PhD, CEO of Foamix. “We believe the positive data from our clinical trial could support advancement into Phase 3, and look forward to reviewing these results with the FDA. Our goal is to bring innovative therapies to market in order to address the unmet needs of patients suffering from various dermatological conditions. Based on our current results, FMX103 has the potential to provide significant benefits to the millions of patients who currently struggle with the physical effects of rosacea and the quality of life impact inherent with this disease.”