Foamix Pharmaceuticals Ltd.’s FMX103 1.5% Topical Minocycline Foam for rosacea performed well in an integrated efficacy analysis of two pivotal Phase 3 clinical trials presented at the 17th Annual South Beach Symposium in Dermatology in Miami, Florida.
The U.S. Food and Drug Administration (FDA) accepted the filing of a New Drug Application for FMX103 for the treatment of moderate to severe papulopustular rosacea in adults with the action date set for June 2nd, 2020 under the Prescription Drug User Fee Act (PDUFA).
The integrated efficacy analysis compared FMX103 to vehicle from 2 identical Phase 3 studies (FX2016-11 and FX2016-12) with 1,522 subjects (1,009 subjects received FMX103 and 513 subjects received vehicle) after 12 weeks of once-daily application.
In the combined analysis of both pivotal Phase 3 studies, FMX103 demonstrated statistically significant benefit compared to vehicle foam on both co-primary endpoints.
There was a significantly greater reduction of inflammatory lesion counts from Baseline to Week 12 for FMX103 compared to vehicle (-18.0 vs. -14.9; p<0.001), respectively. Moreover, a significantly greater number of subjects receiving FMX103 achieved Investigator Global Assessment of Rosacea Severity (IGA) 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 FMX103 when compared to vehicle was observed for both co-primary endpoints for all supporting sensitivity analyses.
In a subgroup analysis of disease severity, FMX103 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 FMX103 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; p<0.001), respectively.
The FMX103 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 FMX103 treatment on disease improvement as early as week 4.