Foamix Pharmaceuticals Doses First Patient in Phase 3 Trial

Foamix Pharmaceuticals has dosed the first patient in its phase 3 program to evaluate the efficacy and safety of its topical minocycine foam 1.5%, FMX103, for the treatment of moderate-to-severe rosacea. The design and clinical endpoints for this phase 3 program are based on the results of the company’s phase 2 study, conducted in Germany with 233 rosacea patients, and recent end-of-phase 2 meeting with the FDA. The company expects topline data in mid-2018.

The primary efficacy endpoints are the proportion of patients achieving success at week 12 based on an investigator’s global assessment, and the mean change from baseline in inflammatory lesion counts in each treatment group at week 12.

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