Phase III clinical trials for FMX 103 show benefits in papulopustular rosacea.- Foamix Pharma

Foamix Pharmaceuticals announced results from an integrated efficacy analysis on the two pivotal Phase III clinical trials for FMX 103 (minocycline, 1.5% foam) currently under review by the FDA for the treatment of moderate to severe papulopustular rosacea in adults. The integrated efficacy analysis compared FMX 103 to vehicle from 2 identical Phase III studies (FX2016-11 and FX2016-12) with 1,522 subjects (1,009 subjects received FMX 103 and 513 subjects received vehicle) after 12 weeks of once daily application. In the combined analysis of both pivotal Phase III studies, FMX 103 demonstrated statistically significant benefit compared to vehicle foam on both co-primary endpoints. Significantly greater reduction of inflammatory lesion counts from Baseline to Week 12 for FMX 103 compared to vehicle (-18.0 vs. -14.9; p<0.001), respectively. significantly greater number of subjects receiving fmx 103 achieved iga treatment success defined as an iga score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement at week 12, (50.6% vs. 41.0%; p><0.001), respectively. statistical superiority of fmx 103 when compared to vehicle was observed for both co-primary endpoints for all supporting sensitivity analyses. in a subgroup analysis of disease severity, fmx 103 demonstrated statistically significant efficacy over vehicle in both baseline severity groups: iga 3 (“moderate”) and iga 4 (“severe”). for subjects assessed as having severe papulopustular rosacea (iga 4) at baseline in each study. the fmx 103 integrated treatment group demonstrated a significantly higher reduction of inflammatory lesions compared to the vehicle integrated treatment group from baseline to week 12, (-26.0 vs. -15.1), respectively. the fmx 103 integrated treatment group demonstrated a significantly higher proportion of subjects achieving iga treatment success compared to the vehicle integrated treatment group at week 12, (36.8% vs. 14.9%; p="0.003)," respectively. the integrated efficacy analysis further demonstrated the effect of fmx 103 treatment on disease improvement as early as week 4. the new data have been presented at the 17th annual south beach symposium in dermatology.>