Shares of Foamix Pharmaceuticals (NASDAQ: FOMX) dove 50% this morning following the company’s report of topline results from its two phase 3 clinical trials investigating FMX101 (Trial 04 and Trial 05) in patients with moderate-to-severe acne. The two co-primary endpoints were the absolute change in the number of inflammatory lesions (papules and pustules); and the proportion of patients achieving success at week 12, as defined by an Investigator’s Global Assessment (IGA) score of “clear” or “almost clear” and at least a two-grade improvement from baseline at week 12. FMX101 did not demonstrate statistical significance of IGA success in Trial 04. However, in the intent-to-treat analysis, FMX101 demonstrated statistical significance compared to vehicle on both co-primary endpoints in Trial 05. “Our team has not yet received the full data set and we intend to provide an update on the program as soon as we complete our analysis. As we have previously announced, the safety extensions for trials 04 and 05 are fully enrolled and continue as planned,” CEO Dov Tamarkin, Ph.D., stated in the news release.
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About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. The company’s clinical stage product candidates include FMX101, a novel minocycline foam for the treatment of moderate-to-severe acne, FMX103 for the treatment of moderate-to-severe rosacea, FMX102 for the treatment of impetigo, and FDX104, a doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs. In addition, Foamix has development and license agreements relating to its technology with various pharmaceutical companies including Bayer HealthCare and others. For more information, please visit www.foamixpharma.com.
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