On November 10, 2025, MannKind Corporation announced that it is discontinuing its Phase 3 clinical trial evaluating nebulized inhalation suspension of clofazimine (MNKD-101") for the treatment of refractory nontuberculous mycobacterial (NTM) lung disease (the ICoN-1 Study). The decision to discontinue the trial follows an analysis of sputum culture conversion data, conducted as part of routine study monitoring and in accordance with the trial protocol, for the first 46 participants who had completed the double-blind treatment phase of the study. None of these 46 participants showed evidence of sputum culture conversion, raising concerns regarding the likelihood of achieving the study's key primary endpoint.
Following an ad hoc meeting of the data safety monitoring board ("DSMB") for the ICoN-1 Study on November 8, 2025, the DSMB reviewed the data and agreed with the decision to discontinue the trial due to futility. In this meeting and in all pastDSMB meetings, no safety issues were found. The Company intends to investigate the reasons for this outcome and use the findings to help guide the ongoing development of MNKD-102, the dry powder formulation of clofazimine, which is in the process of advancing from pre-clinical development towards Phase 1.
