FMX103 meets efficacy endpoints in treating papulopustular rosacea

FMX103 minocycline foam demonstrated statistically significant efficacy in the reduction of inflammatory lesions in a phase 2 clinical trial for treating papulopustular rosacea, according to Foamix Pharmaceuticals.

Researchers conducted a phase 2 trial on 233 patients with moderate-to-severe papulopustular rosacea 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, according to a Foamix press release. 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.

There as a significant reduction in the number of papules and pustules in both dosages compared with vehicle (P < .001), using ANCOVA intent-to-treat analysis. There was a mean reduction in lesion count compared with baseline of 21.1 for the 1.5% dose, 19.9 for the 3% dose and 7.8 for vehicle, according to the release.

“Both the 1.5% and 3% doses of FMX103 were significantly better compared to vehicle in reducing the IGA score by 2 grades and in reaching a ‘clear’ (score = 0) or ‘almost clear’ (score = 1) rating at week 12 (P < .01 and P < .05, respectively, Cochran-Mantel-Haenszel test),” according to the release.

Both doses of FMX103 were efficacious, with no statistically significant differences between the doses in the IGA scores, the release reported.

Four patients discontinued the study due to adverse event, including three in the 3% dosage group and one patient in the vehicle cohort. There were no serious treatment related adverse events reported, according to the release.

“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,” Dov Tamarkin, PhD, CEO of Foamix, stated in the release

Reference: www.foamixpharma.com