Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) shares were last seen up early on Wednesday after the company announced a solid performance in its late-stage trial for moderate-to-severe acne.
Specifically, the company announced top-line results of its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne. The study met both co-primary endpoints of absolute change from baseline in inflammatory lesion count at Week 12, and Investigator Global Assessment (IGA) treatment success at Week 12.
The safety profile of FMX101 was found to be consistent with that determined from the two prior Phase 3 studies (FX2014-04 and FX2014-05). Foamix plans to continue to share data from this study as they become available over the remainder of 2018.
David Domzalski, CEO of Foamix, commented:
We are extremely pleased with the topline results of this confirmatory Phase 3 trial. These study results should support a finding that FMX101 appears to be safe and effective in the treatment of moderate-to-severe acne. This is the most significant milestone to date for Foamix and brings us closer to helping patients who struggle with the physical and psycho-social effects of acne. If approved, we believe FMX101 would be the first topical minocycline product available for patients in the United States.
Shares of Foamix traded up more than 17% early Wednesday at $6.97, with a consensus analyst price target of $16.40 and a 52-week trading range of $4.40 to $7.45.