FDA Approves MannKind's Phase 3 NTM Lung Disease Trial for Clofazimine Inhalation

MannKind Corporation, a business dedicated to creating and selling novel inhaled treatments for endocrine and rare lung diseases, has received the green light from the FDA to start a Phase 3 trial for MNKD-101, an inhaled Clofazimine suspension. This drug is intended to treat nontuberculous mycobacterial (NTM) lung disease, a condition that has been increasing in prevalence and poses a significant health risk globally.

The CEO of MannKind, Michael Castagna, highlighted that oral Clofazimine has been a treatment for NTM lung disease, but by reducing the dosage and delivering it directly to the lungs, the company aims to improve dosing, tolerability, and safety. The upcoming Phase 3 trial, known as ICoN-1, is set to begin in the U.S. by the end of the second quarter of 2024 and will be expanded internationally in the latter half of the year. This trial will be a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of the inhaled suspension when added to standard therapy for adults with NTM lung disease caused by Mycobacterium Avium Complex (MAC).

Dr. Burkhard Blank, MannKind's Executive Vice President of R&D and Chief Medical Officer, emphasized the need for better treatment options for NTM lung disease, which currently requires the use of multiple medications with significant adverse reactions and safety concerns. The company believes that MNKD-101 could provide a safer, more tolerable, convenient, and effective alternative.

NTM infection is a growing concern due to its increasing prevalence, impact on life span, and effect on daily living. NTM bacteria are naturally present in the environment and can cause symptoms such as cough, fatigue, and a decline in lung function. Individuals with conditions like COPD, asthma, and bronchiectasis are more susceptible to NTM infections.

The disease is more prevalent in women over 65 and is more common among Caucasians and Asians. In 2022, there were approximately 122,000 NTM patients in the U.S. and 159,000 in Japan, with up to 20% of these cases being refractory. The disease is growing at an estimated annual rate of 8%.

MannKind is committed to developing innovative inhaled therapeutics to address serious medical needs, focusing on diseases like diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension. Their technologies, including dry-powder formulations and inhalation devices, are designed to deliver medicine rapidly and conveniently to the deep lung for local action or systemic circulation.