Moberg Pharma has announced that patient enrollment has started in U.S., Canada and Germany in the Phase 3 program investigating MOB-015 for the treatment of onychomycosis.
MOB-015 is being evaluated over 52 weeks in two randomized, multicenter, controlled Phase 3 studies. The primary endpoint in both studies is the proportion of patients achieving complete cure of their target nail. In total, approximately 700 patients are expected to be enrolled in the two studies.
In addition to the previously announced approvals of a North American Phase 3 study from the FDA and Health Canada, a European Phase 3 study was recently approved by the regulatory authority in Germany. Moberg Pharma is also expecting approval from the Polish authorities.
“The start of the patient enrollment in the Phase 3 program for MOB-015 is a major milestone for Moberg Pharma,” said Peter Wolpert, CEO of Moberg Pharma. “Our long-term vision is to become a global leader in onychomycosis and we believe that MOB-015 has the potential to establish a new standard of care. The Phase 3 studies have been designed to support registration in North America, Europe and other major markets.”