Foamix begins dosing in phase 3 study of minocycline foam for acne

Foamix Pharmaceuticals announced that the first patient has been dosed in its third phase 3 study to measure the efficacy and safety of FMX101, its topical minocycline foam 4%, in patients with moderate-to-severe acne.

"During a recent Type B meeting, the FDA confirmed that statistically significant findings from a third study would constitute replication of the Study FX2014-05 results, and would be sufficient to establish an efficacy claim,” David Domzalski, CEO of Foamix, stated in a news release. “This confirmation supports our plans for conducting a third phase 3 study.”

FX2017-22, a double-blind, vehicle-controlled study, will enroll 1,500 patients with moderate-to-severe acne at approximately 0 sites throughout the U.S., according to the release. Patients will be randomized 1:1 to either 4% minocycline foam or vehicle, with once daily treatment for 12 weeks.

The proportion of patients achieving a score of "clear" or "almost clear" and at least a 2 category improvement from baseline using the Investigator's Global Assessment at week 12, and the mean change from baseline in inflammatory lesion counts in each treatment group at week 12 are primary endpoints of the study, according to the release.

Reported adverse events, tolerability, clinical laboratory tests and vital signs will be included in the safety measures.

Reference: www.foamix.co.il