MannKind receives clearance in Japan to begin Phase 3 study on Clofazimine

MannKind announced that it has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, to initiate the Phase 3 study, or ICoN-1, of Clofazimine Inhalation Suspension for the treatment of NTM lung disease. The global study is now cleared by health authorities to proceed in four countries, U.S., Japan, South Korea and Australia, with a fifth, Taiwan, expected in 4Q. The ICoN-1 study was initiated in the United States in June 2024 and had its first patient randomized in September. In all, approximately 230 eligible participants will be enrolled and randomized at more than 100 sites across the U.S. and globally to ensure a minimum of 180 participants are evaluable for efficacy.