Foamix Announces Publication of Phase 3 Studies Evaluating FMX103 for the Treatment of Papulopustular Rosacea in Journal of the American Academy of Dermatology
February 6, 2020 at 8:00 AM EST
PDF Version
REHOVOT, Israel, and BRIDGEWATER, N.J., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, announced today the publication of the Company’s Phase 3 studies FX2016-11 and FX2016-12 (Studies 11 & 12) in the Journal of the American Academy of Dermatology (JAAD). Studies 11 and 12 were conducted by Foamix to support the New Drug Application (NDA) submission of FMX103 (minocycline, 1.5% foam), which is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe papulopustular rosacea in adults.
“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. Iain Stuart, Chief Scientific Officer of Foamix. “We are proud that JAAD has accepted studies FX2016-11 and FX2016-12 (Studies 11 & 12) for publication, ensuring that a broad range of dermatology healthcare professionals globally will have access to these important data.”
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.
