Foamix Announces Completion of Enrollment in Phase 2 Clinical Trial of Minocycline Foam (FMX103) for Treatment of Papulopustular Rosacea
REHOVOT, Israel and BRIDGEWATER, N.J., May 03, 2016 (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 completion of enrollment 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.
"We are pleased to have reached full enrollment of our Phase 2 study earlier than we originally anticipated," said Dov Tamarkin, PhD, Chief Executive Officer of Foamix Pharmaceuticals. "There is a significant unmet need for safe and effective alternatives for the treatment of rosacea. We believe FMX103 has the potential to offer meaningful benefits over the current standard of care, and we look forward to receiving the results of this study later this year."
In this Phase 2 double-blind, randomized, placebo-controlled trial, 233 patients have been enrolled in 18 sites throughout Germany. Patients were 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 evaluation. The primary endpoints are safety, tolerability and efficacy in the treatment of moderate-to-severe papulopustular rosacea. Foamix expects to develop FMX103 in the U.S. under the FDA's 505(b)(2) regulatory pathway.
Foamix expects to report top-line results from this Phase 2 study by the end of the year.
Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead. It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that adversely affect quality of life. 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.
There is no known cure for rosacea. Mild papulopustular rosacea is treated by topical antimicrobials (metronidazole, clindamycin, sulfacetamide-sulphur and ivermectine), azelaic acid or retinoids, while systemic antibiotics such as minocycline and doxycycline are the mainstay for the treatment of moderate-to-severe rosacea, often in combination with topical agents (Drugs (2014) 74:1457-1465)
About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy.
Our clinical stage product candidates include FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne, FMX102 for the treatment of impetigo, FMX103 for the treatment of rosacea, and FDX104, our doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs.
In addition, we have development and license agreements relating to our technology with various pharmaceutical companies including Bayer HealthCare, Merz, Allergan and Prestium.
For more information, please visit www.foamixpharma.com.
Forward Looking Statements
This press release may include forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations. Forward-looking statements are based on our current knowledge and our present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, unexpected delays, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne market, denial of reimbursement by third party payors or inability to raise additional capital. We discuss many of these risks in greater detail under the heading "Risk Factors" in our most recent Annual Report on Form 20-F (File No. 161477078) filed on March 7, 2016, and elsewhere in that Annual Report. Any forward-looking statements that may be made herein speak only as of the date of this release and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.