Moberg Pharma has completed the recruitment of 365 patients with onychomycosis (nail fungus) for the ongoing MOB-015 phase 3 study in North America.
The aim is to provide a pivotal part of the clinical data set for registration and commercialization of MOB-015. Topline results are expected in the fourth quarter of 2019, reports the company.
Phase 3 studies for MOB-015 are progressing in the EU and North America evaluating the efficacy and safety of MOB-015, Moberg Pharma’s proprietary topical formulation of terbinafine. The primary endpoint for both trials is the proportion of subjects achieving complete cure of their target nail at 52 weeks. The enrollment to the North American study has now been completed with 365 patients randomized at 32 sites in the U.S. and Canada. Topline results from the North American Phase 3 study are expected in the fourth quarter of 2019.
“Completing the enrollment in North America is an important milestone and the result of excellent work from the team. I am very pleased with the progress and the rigorous screening process which increases the probability of strong phase 3 results”, says Peter Wolpert, Moberg Pharma’s CEO.
Source: Moberg Pharma press release