Foamix begins dosing in phase 3 trials of minocycline foam for rosacea

Foamix Pharmaceuticals Ltd announced that the first patient has been dosed in a phase 3 program to measure the efficacy and safety of FMX103, topical minocycline foam 1.5%.

The program consists of two studies, with each enrolling approximately 750 patients with moderate-to-severe papulopustular rosacea into a 12-week double-blind, vehicle-controlled phase, followed by a 9-month open-label safety extension phase with the active 1.5% minocycline foam, according to a press release.

The studies are being conducted at multiple sites in the United States.

In the initial 12 weeks of the study, patients will be randomized on a 2:1 basis (1.5% minocycline foam vs vehicle) and treated once daily.

The proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment of “clear” or “almost clear” and at least a 2-grade improvement from baseline, and the mean change from baseline in inflammatory lesion counts in each treatment group at week 12 will be used as primary efficacy endpoints, according to the release. Reported adverse events, assessments of tolerability, clinical laboratory tests and vital signs will be used to measure safety of the product.

Patients who complete the initial 12 weeks of treatment will have the option to continue in a long-term extension to evaluate the safety of intermittent use of FMX103 for up to an additional 9 months, according to the release.

Foamix reported that its phase 2 clinical trial involving 233 patients with moderate-to-severe rosacea enrolled at 18 sites throughout Germany demonstrated significant efficacy for the 1.5% concentration of minocycline foam compared to a vehicle control group.

The company expects top-line data from the phase 3 studies in mid-2018, according to the release.

Reference: www.foamix.com