MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared the company?s Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study for the treatment of nontuberculous mycobacterial (NTM) lung disease. This single registrational study, identified as ICoN-1, anticipates getting underway by end of second quarter 2024 in the U.S., and internationally in the second half of 2024. ICoN-1 is a multi-national, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Clofazimine Inhalation Suspension when added to guideline-based therapy in adults with refractory NTM lung disease caused by Mycobacterium Avium Complex (MAC), followed by an open-label extension.

Pulmonary NTM infection is recognized as a major global health concern due to its rising prevalence worldwide, association with shortened life span and significant impact on patients? daily living. NTM is a group of bacteria naturally found in their environment, including water and soil, that can lead to cough, fatigue, a reduction in lung function, and poor quality of life.

While most people are exposed to NTM daily, the organisms generally do no harm. Individuals with underlying conditions such as COPD, asthma, and bronchiectasis are prone to NTM getting established in the lungs creating an infection and progressive worsening of lung function. NTM lung disease is more common in women over the age of 65, with a predominance in those of Caucasian and Asian descent.

In 2022, there were approximately 122,000 and 159,000 patients living with NTM in the U.S. and Japan, respectively, with as much as 20% of those cases being refractory. The disease state is on the rise, with an estimated annual growth rate averaging 8%.