Foamix plans third phase 3 trial for minocycline foam to treat acne with NDA as goal

Foamix Pharmaceutical recently announced that based on the results of its first two phase 3 trials, it will conduct a third U.S. phase 3 trial of FMX101 to treat patients with moderate-to-severe acne.

The trial is slated to begin mid-year, and if results are positive, the trial could form the basis of a new drug application (NDA) for FMX101 (minocycline foam 4%), which the company plans to submit in the second half of 2018, according to a news release from Foamix

“The totality of the clinical efficacy results from FMS101, including the further analysis we conducted of the phase 3 data, are positive,” Dov Tamarkin, PhD, CEO of Foamix, stated in the release. “Inconsistent results were noted in only one of the efficacy endpoints and the product appears to be safe and well tolerated. Based on our analysis of the efficacy results from Trials 04 and 05, we plan to conduct a third trial to validate the results, with the same co-primary endpoints and enrollment criteria but with a substantially increased sample size.”

Target patient enrollment for the new trial is 1,500, and patients will be randomized to receive either FMX101 or vehicle foam once daily for 12 weeks. Mean change from baseline in the inflammatory lesion count and proportion of patients with Investor’s Global Assessment scores of “clear or “almost clear” with improvement of at least two grades from baseline are co-primary endpoints, according to the release.

Foamix reported that the trial is to be conducted at approximately 30 clinical sites in the U.S.

Reference: www.foamixpharma.com