Moberg Pharma has announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application and that a No Objection Letter has been received from Health Canada to begin its Phase 3 trial for MOB-015 in the treatment of onychomycosis.
This allows Moberg Pharma to start enrolling patients in the U.S. and Canada pending approval from the Institutional Review Board (IRB/independent ethics committee). The approvals concern a randomized, multicenter, vehicle-controlled Phase 3 study. The patients will be evaluated over 52 weeks and the primary endpoint will be the proportion of patients achieving complete cure of their target nail. The company expects to start enrollment in the third quarter of this year.