MannKind Corporation announced that the FDA has cleared the company’s IND for the ICoN-1 Phase 3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). The company said that it expects to initiate the study in the US by mid-2024 and elsewhere by the end of the year.
In January 2023, MannKind announced plans for a Phase 2/3 study of MNKD-101; however, later in the year, the company filed a notice with the SEC stating that the trial would be delayed due to a fire at the facility that was supposed to manufacture clinical trial supplies of the inhalation suspension.
MannKind CEO Michael Castagna commented, “Oral clofazimine has been utilized as a treatment option for patients living with NTM lung disease and we believe that by reducing the dose and administering it directly to the lung we can demonstrate improved dosing, tolerability and safety. Advancing this program to a Phase 3 trial, we are encouraged that MNKD-101 could potentially address a serious unmet need that is on the rise globally – particularly in the US and the Asia Pacific region.”
Read the MannKind press release.
