Foamix Announces Enrollment of First Patient in Phase 2 Acne Clinical Trial for FCD105 Minocycline 3% and Adapalene 0.3% Combination Foam
“FCD105 combines minocycline and adapalene, which are two leading agents for treating inflammatory and non-inflammatory comedonal acne lesions, respectively, in a convenient, foam-based product. We currently expect topline data from this study in mid-2020," said
The Phase 2 clinical trial is expected to enroll approximately 400 patients, aged 12 years and older, with moderate-to-severe acne vulgaris. This prospective, randomized, double-blind, vehicle-controlled trial will be conducted at multiple sites throughout
The primary endpoints are: 1) the proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment (success is defined as a score of “clear” or “minimal” and at least a 2 category improvement from baseline), 2) the mean change from baseline in inflammatory lesion counts in each treatment group at week 12, and 3) the mean change from baseline in non-inflammatory lesion counts in each treatment group at week 12. Safety evaluation will include reported adverse events, skin tolerability assessments, physical examinations and vital signs.
FCD105 is Foamix’s proprietary 3% minocycline, 0.3% adapalene combination foam formulation intended for the treatment of moderate-to-severe acne vulgaris. FCD105 combines the bacteriostatic and anti-inflammatory properties of minocycline with the third-generation retinoid, adapalene, which acts in regulating the differentiation of follicular epithelial cells. Oral minocycline and topical adapalene products are approved for use in the treatment of acne vulgaris in the
About Acne Vulgaris
Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. It 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. Acne 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.
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 and FCD105 which are intended for the treatment of moderate-to-severe acne vulgaris and FMX103 which is intended for the treatment of moderate-to-severe papulopustular rosacea. We continue to pursue research and development of our proprietary, innovative topical technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies.
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
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the future development plans of FMX101 and FMX103, the PDUFA date of FMX101, the potential approval of FMX101 by the
|Contact:||U.S. Investor Relations|
|Ilan Hadar, CFO||Michael Rice|
|Foamix Pharmaceuticals Ltd.||LifeSci Advisors, LLC|
Source: Foamix, Ltd.