Dec 9, 2019: Moberg Pharma announces that MOB-015 (topical terbinafine) met the primary endpoint and also key secondary endpoints in the North American Phase 3 study including 365 patients with mild to moderate toenail onychomycosis (nail fungus).
At week 52, considerably more patients reached complete cure for MOB-015 than for vehicle (p=0.019), following 48 weeks of daily treatment.
The purpose of this randomized, multicenter, controlled clinical Phase 3 study was to evaluate the efficacy and safety of MOB-015 in patients with mild to moderate distal subungual onychomycosis (DSO) affecting 20-60 percent of the great toenail.
The study was conducted at 32 sites in the U.S. and Canada along with 365 patients, 246 patients receiving MOB-015 and 119 patients receiving vehicle.
Patients received treatment during 48 weeks and had the last follow-up assessment at week 52. in general MOB-015 was well tolerated.
cure rate in the study is extraordinarily high for a topical treatment, due to fungicidal activity of terbinafine in MOB-015. http://www.mobergpharma.com/press-releases/2019-12-09/moberg-pharma-meets-primary-endpoint-mob-015-phase-3-study-treatment