MannKind Corporation announced that it has discontinued the Phase 3 ICoN-1 study of MNKD-101 nebulized clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease “due to futility” after analysis of data from the first 46 subjects. The trial was initiated in 2024 and was expected to enroll 234 patients at sites in the US, in Japan, Australia, South Korea, and Taiwan.
According to the announcement, none of the first 46 participants who completed the double-blind treatment portion of the study experienced sputum culture conversion, which was the primary endpoint. No safety concerns were identified, consistent with results from a Phase 1 trial of the inhalation suspension announced in 2022. MNKD-101 received Fast Track designation from the FDA for the treatment of NTM in May 2024.
MannKind Chief Medical Officer Ajay Ahuja commented, “We are disappointed that the nebulized formulation did not demonstrate efficacy in this patient population. However, we remain hopeful regarding the potential of MNKD-102, our dry powder inhalation (DPI) formulation of clofazimine, which has been progressing toward Phase 1 development. We are committed to understanding the factors that contributed to this outcome in the nebulized formulation and applying those insights to guide our future development efforts.”
Read the MannKind Corporation press release
