Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) rose Wednesday, after the company disclosed that a Phase 3 trial for the company's FMX101 acne candidate met both co-primary endpoints.
The Israeli-based company, with U.S. headquarters in Bridgewater, New Jersey, announced Tuesday the topline 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 (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline.
CEO David Domzalski declared, "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."
The double-blind, randomized, vehicle-controlled Phase 3 trial enrolled 1,507 patients with moderate-to-severe acne at 89 sites in the United States. Patients were randomized to receive either FMX101 minocycline foam (4%) or vehicle foam once daily for 12 weeks.
Foamix calls itself "a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology."
Shares sprinted ahead 48 cents, or 8.1%, to $6.40.
