Foamix Announces Publication of Phase 3 Studies Evaluating FMX103 for the Treatment of Papulopustular Rosacea in Journal of the American Academy of Dermatology
REHOVOT, Israel, and BRIDGEWATER, N.J.,
“The publication of these data represents another step forward in our efforts to bring an innovative, topical medication to market for moderate to severe papulopustular rosacea, which can be challenging to treat and represents an unmet need in dermatology with few new treatment developments in recent years,” said Dr.
Highlights from the Phase 3 Program:
- Both studies demonstrated high statistically significant superiority of FMX103 compared with vehicle in both primary endpoints of absolute inflammatory lesion reduction and Investigator’s Global Assessment (IGA) treatment success at Week 12 where approximately half of subjects achieved treatment success as defined by the latter endpoint.
- There was a statistically significant reduction in inflammatory lesions versus vehicle as early as Week 4 of treatment, and all subsequently assessed timepoints throughout the entire treatment course of the study.
- Subjects were no more likely to experience treatment-emergent adverse events (TEAEs) from FMX103 than from vehicle treatment. The majority of TEAEs were mild to moderate.
- More than 95% of subjects using FMX103 had skin tolerability scores of none or mild at the treatment application site at Week 12.
- Specifically for erythema as part of skin tolerability assessments, 5.5% and 6.6% of subjects who received FMX103 in Studies 11 and 12 respectively, were assessed as being clear or almost clear at Baseline. At Week 12, 40.9% and 48.3% of subjects who received FMX103 respectively were assessed as clear or almost clear of erythema.
About Papulopustular Rosacea
Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead. It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can adversely affect quality of life. Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in the
Foamix is a specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world’s first topical minocycline, AMZEEQ. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company’s dermatology products and in other products currently in development: FMX103 for the potential treatment of moderate to severe papulopustular rosacea and FCD105 for the potential treatment of moderate to severe acne.
Foamix is a different type of specialty pharmaceutical company by design, driven to see the solutions, overcome barriers in all aspects of business, and reimagine what’s possible for conditions with high unmet needs.
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This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release which are not historical facts are forward-looking statements, including, but not limited to, statements regarding the future expectations, plans and prospects for Foamix; the Company’s future development plans regarding FMX103, the potential approval of FMX103 by the
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Source: Foamix, Ltd.