Confirmation today that Foamix’s minocycline based FMX103 is still in clinical trials as a rosacea treatment. A press release from the company tells us that the Phase 2 trials have completed. The trial compared 3% minocycline foam, 1.5% minocycline foam and the vehicle foam.

Foamix are hopeful that their foam formulation of topical minocycline can be proven as a safe and effective treatment for the papules and pustules of rosacea. We first learnt of a clinical trial for Foamix’s topical minocycline (called FXFM244) in 2010. This press release is confirmation that this new formulation is still in active development as a new rosacea treatment.

Foamix Reports First Quarter 2016 Financial Results and Provides Business Update

Rehovot, Israel May 10, 2016 – Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX)

FMX103, for the treatment of moderate-to-severe papulopustular rosacea, has the same active ingredient, minocycline, as our lead candidate, FMX101, for acne.  Based on the positive clinical data we have generated in acne and the dermatological similarities between rosacea lesions and inflammatory acne lesions, we believe FMX103 can be a safe and effective topical treatment for rosacea. FMX103 has the potential to offer significant advantages over the current standard of care.

We recently announced the completion of patient enrollment in our Phase 2 trial of FMX103.  This trial is a double-blind, randomized, placebo-controlled trial in which 233 patients have been enrolled in 18 sites throughout Germany.

Patients are randomized to receive FMX103 (3% minocycline foam), FMX103 (1.5% minocycline foam) or vehicle foam, once daily over 12 weeks, followed up by a 4-week post-treatment evaluation.

The primary endpoints are safety, tolerability and efficacy.  We expect to receive the results of this study later this year.

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