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Foamix’s FMX103 meets efficacy endpoints in phase 2 trial for papulopustular rosacea

A phase 2 clinical trial evaluating Foamix Pharmaceuticals' FMX103 to treat moderate-to-severe papulopustular rosacea (PR) demonstrated statistically significant improvement compared with vehicle in the main efficacy endpoints.

The company conducted the trial on 233 patients at 18 sites in Germany, who were randomized to receive one or two doses of FMX013 (3% or 1.5% minocyline foam) or vehicle foam once daily for 12 weeks.

Primary endpoint was absolute change in number of inflammatory lesions, including papules and pustules, while secondary endpoint was improvement of the Investigator Global Assessment (IGA) of severity.

Foamix said both doses of FMX103 were statistically significantly better than vehicle in reducing IGA score by two grades and in reaching "clear" (score = 0) or "almost clear" (score = 1) at Week 12 (p<0.01 and p<0.05, respectively).

FMX103 was safe and well-tolerated. There were no severe treatment-associated adverse events (AEs) and few subjects overall reported any treatment-related AEs.

A total of four subjects discontinued the study due to an adverse event, the company noted.

Foamix Pharmaceuticals CEO Dov Tamarkin said: “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. 

“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.”