MannKind: FDA approves IND applicaiton for MNKD-101

MannKind announced that the U.S. FDA has cleared the company’s Investigational New Drug application for MNKD-101, enabling the initiation of a Phase 3 study for the treatment of nontuberculous mycobacterial lung disease. This single registrational study, identified as ICoN-1, anticipates getting underway by end of 2Q 2024 in the U.S., and internationally in the second half of 2024. ICoN-1 is a multi-national, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Clofazimine Inhalation Suspension when added to guideline-based therapy in adults with refractory NTM lung disease caused by Mycobacterium Avium Complex, followed by an open-label extension.