Foamix Announces Enrollment of First Patient in Phase 2 Clinical Trial of FMX103 in Papulopustular Rosacea
REHOVOT, Israel and BRIDGEWATER, N.J., Oct. 20, 2015 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), ("Foamix Pharmaceuticals"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced the enrollment of the first patient in a Phase 2 clinical trial of FMX103 for the treatment of papulopustular rosacea.
Papulopustular rosacea is a chronic skin disorder characterized by facial redness and inflammatory lesions. It affects more than 16 million people in the U.S. alone. The most common treatments for rosacea are topical therapies such as metronidazole and azelaic acid, as well as the oral antibiotics minocycline and doxycycline.
"There is a huge demand for new safe and effective topical treatments," said Dov Tamarkin, Chief Executive Officer of Foamix Pharmaceuticals. "FMX103 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."
The Phase 2 study is a 210 patient, double-blind, randomized placebo-controlled trial to be conducted in several sites throughout Germany. Patients will be randomized to receive FMX103 (3% minocycline foam), FMX103 (1.5% minocycline foam) or vehicle foam over 12 weeks, followed up by a 4-week post-treatment follow-up evaluation. The primary endpoints will be safety, tolerability and efficacy in the treatment of moderate-to-severe papulopustular rosacea. Foamix plans to support and expedite the filing of an NDA for FMX103 in the U.S. under the FDA's 505(b)(2) regulatory pathway.
Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead. There is no known cure. Rosacea is most frequently seen in adults between 30 and 50 years of age. Although the exact root cause of rosacea remains unknown, both genetic and environmental factors are thought to have an impact on causing this disease.
About Foamix Pharmaceuticals
Foamix Pharmaceuticals is a clinical-stage specialty pharmaceutical company focused on developing and commercializing its proprietary minocycline foam for the treatment of acne and other skin conditions. Foamix Pharmaceuticals' lead product candidate FMX101 for moderate-to-severe acne is a novel topical foam formulation of the antibiotic minocycline. Foamix Pharmaceuticals also has early-stage stable foam formulations of various drugs for the treatment of common dermatological indications.