REHOVOT, Israel, and BRIDGEWATER, New Jersey, Nov. 28, 2016 /PRNewswire/ -- Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced that it has completed patient enrollment according to plan in the Company's two Phase 3 clinical trials to evaluate the efficacy and safety of FMX101, a topical 4% minocycline foam, in the treatment of moderate-to-severe acne. Foamix is conducting the two Phase 3 pivotal trials simultaneously, and expects to report top-line results in the first half of 2017.
"Completing enrollment of these Phase 3 clinical trials is an important milestone for our lead candidate, FMX101, as it moves us closer to providing an effective, convenient, first-in-class topical treatment for patients with moderate-to-severe acne," said Dr. Dov Tamarkin, Chief Executive Officer of Foamix. "I look forward to sharing the clinical trial results in the first half 2017. If approved, FMX101 is expected to be the first FDA-approved topical antibiotic treatment for moderate-to-severe acne, a skin disorder that affects millions of people every year with potentially significant psychological and social implications."
About FMX101 Phase 3 Program
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% 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.
A total of 961 patients with moderate-to-severe acne were enrolled between the two trials.
Patients who complete the 12 weeks double-blind portion 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.
Foamix expects to report top-line results from the blinded phase of the clinical trials in the first half of 2017.
About Moderate-to-Severe Acne
Acne, the most common skin disorder in the U.S., affects 40 to 50 million Americans and is associated with various psychological and social implications, including anxiety and depression. Currently available topical anti-acne medications are often ineffective in the treatment of moderate-to-severe acne, which afflicts about 20% of the total acne-affected population. In February 2016, the American Academy of Dermatology issued new guidelines of care for acne treatment, which assert that the systemic antibiotics such as minocycline and doxycycline are the mainstay of treatment for moderate-to-severe inflammatory acne, often in combination with topical agents (JAAD, 2016: 74(5), 945–973).
FMX101 is Foamix's proprietary 4% minocycline foam formulation for the treatment of moderate-to-severe acne. 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% concentration of minocycline foam versus the control placebo group, with FMX101 at 4% concentration reducing inflammatory acne lesions by 71% 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% reduction in non-inflammatory lesions. No drug-related systemic side effects were observed. For more information regarding the Phase 2 clinical trial, please visit the company website at www.foamixpharma.com.
The FMX101 application is intended to be filed under the 505(b)(2) regulatory pathway. In a Phase 1 pharmacokinetics study in 30 patients with moderate-to-severe acne, the systemic absorption of minocycline after repeated maximum-dose applications of FMX101 at 4% concentration was compared directly to that of orally-administered Solodyn® (Valeant Pharmaceuticals' minocycline HCl extended release tablets) at doses of approximately 1 mg/kg. This study showed that the bioavailability, or systemic exposure, of minocycline following topical FMX101 administration was approximately 700 times lower than that of Solodyn.
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, FMX103 for the treatment of moderate-to-severe rosacea, FMX102 for the treatment of impetigo, 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 Mylan.
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.