FX.co ★ MannKind Gets FDA Nod For Phase 3 Study Of Clofazimine Inhalation Suspension For NTM Lung Disease

MannKind Corp. (MNKD) made a public announcement on Monday, stating that the Food and Drug Administration (FDA) has approved the phase III study of Clofazimine Inhalation Suspension, a treatment for nontuberculous mycobacterial lung disease.

The phase III research, named ICoN-1, is set to be a multi-national study. It aims to analyze the effectiveness and safety of the Clofazimine Inhalation Suspension with the addition of guideline-based therapy to treat adults with refractory nontuberculous mycobacterial lung disease. The disease is caused by Mycobacterium Avium Complex (MAC) and will next undergo an open-label extension.

The study is scheduled to begin in the United States by the end of the second quarter of 2024. International sites are set to commence their participation in the study during the latter half of 2024.

Michael Castagna, CEO of MannKind, released a statement about the recent developments. He stated, “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."