Foamix Announces Dosing of Last Patient in Third Phase 3 Acne Study for Minocycline Foam FMX101
- Category: Small Molecules
- Published on Monday, 07 May 2018 17:52
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Top-line Results Expected in the Third Quarter of 2018
REHOVOT, Israel, and BRIDGEWATER, NJ, USA I May 07, 2018 I Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced that the final patient has been enrolled and dosed in its third Phase 3 study, FX2017-22, evaluating the efficacy and safety of its topical minocycline foam 4%, or FMX101.
“Completing enrollment in this third Phase 3 study marks a critical milestone in the development of FMX101 for the treatment of moderate-to-severe acne,” said David Domzalski, CEO of Foamix. “We are very pleased by the interest shown by patients and physicians in this study and I look forward to sharing the results in the third quarter of 2018.”
About FX2017-22 Study Design
FX2017-22 is a double-blind, vehicle-controlled, multi-center study conducted in the United States that has been enrolling patients with moderate-to-severe acne. Patients were randomized 1:1 to either FMX101 or vehicle, with once daily treatment for 12 weeks. The primary endpoints are 1) the proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment (with success defined as a score of “clear” or “almost clear” and at least a 2 category improvement from baseline), and 2) the mean change from baseline in inflammatory lesion counts in each treatment group at week 12. Safety evaluation includes reported adverse events, assessments of tolerability, clinical laboratory tests and vital signs. For more information, refer to www.clinicaltrials.gov Identifier: NCT03271021.
A total of 1507 patients were enrolled in FX2017-22 study. If successful, the study results will further support the company’s planned new drug application (NDA) for FMX101, which is targeted for regulatory submission to the U.S. Food and Drug Administration (FDA) before year-end 2018.
Acne is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and other areas of the body. It affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate-to-severe disease that significantly impacts self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.
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 leading clinical stage product candidates are FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative foam technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies including Bayer HealthCare and others.
Foamix uses its website (www.Foamix.com) as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Foamix’s website in addition to following its press releases, filings with the Securities & Exchange Commission (“SEC”), public conference calls, and webcasts.
SOURCE: Foamix Pharmaceuticals