Foamix Announces Publication of Phase 3 FMX101 Acne Study in Journal of American Academy of Dermatology
REHOVOT, Israel and BRIDGEWATER, N.J.,
“We are pleased that the prestigious JAAD has chosen to highlight Study 22 in its current edition,” said Dr.
Highlights from the study:
- The study showed high statistically significant superiority of FMX101 compared with vehicle in both primary endpoints of absolute inflammatory lesion reduction and IGA treatment success at week 12.
- FMX101 also met all secondary endpoints, showing statistically significant improvement in absolute reductions in both inflammatory lesions (papules, pustules and nodules) and non-inflammatory lesions (open and closed comedones).
- There was a statistically significant reduction in inflammatory lesions versus vehicle as early as week 3 of treatment, and all subsequently assessed timepoints throughout the entire treatment course of the study.
- Statistically, participants were no more likely to experience treatment-emergent adverse events (TEAEs) from FMX101 than from vehicle treatment. The majority of TEAEs were mild to moderate.
- More than 95% of participants using FMX101 had no or mild skin tolerability scores at the treatment application site at week 12.
“These data show that FMX101 has potential as both a safe and effective option for patients,” said Dr.
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, our novel minocycline foam being developed for the treatment of moderate-to-severe acne, and FMX103, our novel minocycline foam being developed for the treatment of rosacea. We continue to pursue research & 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
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Source: Foamix, Ltd.