Foamix Announces Dosing of Last Patient in Third Phase 3 Acne Study for Minocycline Foam FMX101
Top-line Results Expected in the Third Quarter of 2018
“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
About FX2017-22 Study Design
FX2017-22 is a double-blind, vehicle-controlled, multi-center study conducted in
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
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.
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
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
Forward Looking Statements
This release includes 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 created by those sections. 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.
|Contact:||U.S. Investor Relations|
|Ilan Hadar, CFO & Country Manager||Michael Rice|
|Foamix Pharmaceuticals Ltd.||LifeSci Advisors, LLC|
Source: Foamix, Ltd.