Moberg Pharma has completed the recruitment of 384 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 in the US. Topline results are expected in January 2025.

The enrollment to the North American study has now been completed with 384 patients randomized at 33 sites in the U.S. and Canada. Topline results are expected in January 2025. The patients are evaluated over 52 weeks and the primary endpoint is the proportion of subjects achieving complete cure of their target nail. The study design builds on the experience gained from the previous Phase 3 studies.

Moberg Pharma cooperate with the same CRO, lead investigator and successful sites from the previous North American study. The purpose of the study is to facilitate market approval in the US as well as strengthen the product's clinical evidence and marketing claims globally.

"Completing the enrollment in North America well ahead of year-end is an important milestone and the result of excellent teamwork and committed investigators. I am very pleased with the progress and the rigorous screening process and positive collaborative atmosphere which increases the probability of strong phase 3 results", says Anna Ljung, CEO of Moberg Pharma AB.