MannKind provides update on Phase 3 ICoN-1 trial of nebulized clofazimine

MannKind (MNKD) announced the discontinuation of its Phase 3 ICoN-1 clinical trial evaluating MNKD-101, a nebulized clofazimine inhalation suspension, for the treatment of refractory nontuberculous mycobacterial, NTM, lung disease. As part of routine study monitoring and in accordance with the trial protocol, an analysis was conducted on sputum culture conversion data from the first 46 participants who completed the double-blind treatment phase. No conversions were observed, prompting concerns regarding the likelihood of achieving the study’s key primary endpoint. Following an ad hoc meeting held on November 8, 2025, the independent Data Safety Monitoring Board reviewed the data and agreed with the decision to discontinue the trial due to futility. Importantly, the DSMB did not identify any safety concerns at any point during the study.