Foamix Pharmaceuticals, a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today 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 – papules and pustules and improvement of Investigator Global Assessment score) for FMX103 compared with the vehicle-treated group.
“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, Ph.D., 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”, he added.
Trial Design and Results
The double-blind, randomized, placebo-controlled Phase 2 trial included 233 subjects with moderate-to-severe rosacea enrolled at 18 sites in Germany. Subjects were randomized to receive either 1 of 2 doses of FMX103 minocycline foam (3% or 1.5%) or vehicle foam once daily over 12 weeks, followed up by a 4-week post-treatment evaluation. The efficacy endpoints were the absolute change in the number of inflammatory lesions – papules and pustules (primary endpoint) and improvement of the Investigator Global Assessment of severity, or IGA (first secondary endpoint). Safety and tolerability were also evaluated.