(RTTNews) - MannKind (MNKD) announced the discontinuation of Phase 3 ICoN-1 clinical trial evaluating MNKD-101, a nebulized clofazimine inhalation suspension, for the treatment of refractory nontuberculous mycobacterial 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. The independent Data Safety Monitoring Board reviewed the data and agreed with the decision to discontinue the trial due to futility.
The company noted that the outcome does not impact the development of MNKD-102, MannKind's dry powder inhalation formulation of clofazimine.
Shares of MannKind are down 10% in pre-market trade on Monday.
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