Patient Enrollment Complete in Phase 3 Acne Trials for Minocycline Foam FMX101

Patient enrollment is now complete for two Phase 3 clinical trials evaluating the efficacy and safety of FMX101, a topical 4 percent minocycline foam for the treatment of moderate-to-severe acne, according to Foamix Pharmaceuticals Ltd.

Foamix is conducting the two Phase 3 pivotal trials simultaneously, and expects to report top-line results in the first half of 2017. A total of 961 patients with moderate-to-severe acne were enrolled between the two trials.

The Phase 3 program consists of two multi-center trials, each with a target enrollment of 450 patients with moderate-to-severe acne.  Patients were randomized on a 2:1 basis (active vs. vehicle), initially into a 12-week double-blind phase, where they are treated topically once daily with either FMX101 (4 percent minocycline foam) or the respective foam vehicle. 

The two co-primary efficacy endpoints of both trials are (1) the absolute change from baseline in inflammatory lesion counts in each treatment group at week 12; and (2) the proportion of patients achieving success at week 12 as defined by an Investigator's Global Assessment (IGA) score of "clear" or "almost clear" (score of 0 or 1) and at least a 2-grade improvement (decrease) from baseline at week 12.  Safety evaluation will include reported adverse events, assessments of tolerability, clinical laboratory tests and vital signs.

Patients who complete the 12 weeks double-blind part of the trials will have the option to continue in a long-term open-label safety extension, aimed to evaluate the safety of intermittent use of FMX101 for up to an additional 9 months.

In 2013, Foamix completed a dose-ranging Phase 2 clinical trial of FMX101 in Israel involving 150 patients aged 12 to 25 with moderate-to-severe acne. This trial demonstrated both clinically and statistically significant efficacy for the 4 percent concentration of minocycline foam versus the control placebo group, with FMX101 at 4 percent concentration reducing inflammatory acne lesions by 71 percent in 6 weeks and maintained that level of efficacy for the remainder of the 12 week trial. Additionally, the effect on non-inflammatory lesions also reached statistical significance at week 12, with a 73 percent reduction in non-inflammatory lesions. No drug-related systemic side effects were observed.