First Site Initiated in Australia for MannKind's Phase 3 Clinical Trial Evaluating Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease

Core Viewpoint - MannKind Corporation has initiated its Phase 3 clinical trial, ICoN-1, for Clofazimine Inhalation Suspension targeting nontuberculous mycobacterial lung disease, with regulatory approvals in multiple countries [1][2][5]. Group 1: Clinical Trial Details - The ICoN-1 study is a multinational, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Clofazimine Inhalation Suspension in adults with refractory NTM lung disease caused by mycobacterium avium complex (MAC) [4]. - Approximately 230 eligible participants will be enrolled across more than 100 sites globally, with a target of at least 180 evaluable participants for efficacy [3]. - The primary endpoint is sputum culture conversion from baseline to the end of Month 6, with a co-primary endpoint in the U.S. focusing on quality of life changes during the same period [4]. Group 2: Regulatory and Patent Information - The U.S. FDA granted Fast Track designation for Clofazimine Inhalation Suspension, which is also recognized as an orphan drug and a qualified infectious disease product (QIDP), potentially providing up to 12 years of market exclusivity [5]. - A patent covering compositions of Clofazimine and methods for treating lung infections has been granted, with expiration set for June 8, 2039 [6]. Group 3: NTM Disease Context - Nontuberculous mycobacterial (NTM) lung infection is a rare but growing global health concern, with an estimated prevalence of over 100,000 cases in the U.S. and over 150,000 in Japan as of 2022 [8]. - The prevalence of NTM is increasing globally, with claims-based studies in the U.S. suggesting an annual rise of 7.5% [8]. - The most common type of NTM lung disease is caused by MAC, accounting for about 80% of cases in the U.S., particularly affecting women over 65 [8].