MannKind Corporation announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the initiation of the Phase 3 ICoN-1 trial of MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease. The company noted that the trial has already been cleared in the US, South Korea, and Australia; and Taiwan is expected to okay the study by the end of this year.
In the US, the FDA cleared the company’s IND for the study in April 2024 and granted Fast Track designation to MNKD-101 for NTM the next month. According to MannKind, the US portion of the trial was initiated in June 2024, and enrollment is underway.
The US study is expected to enroll approximately 230 patients who will receive an 80 mg dose of the inhalation suspension delivered by a PARI jet nebulizer or nebulized placebo daily for 28 days, followed by 56 days off, and then for another 28 days.
Read the MannKind Corporation press release.
