Foamix Announces Completion of Patient Enrollment in Phase 3 Acne Trials for Minocycline Foam FMX101
"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.
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
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
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® (
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
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.
Foamix Pharmaceuticals Ltd.
US Investor Relations
LifeSci Advisors, LLC
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