MannKind’s Inhaled Clofazimine Will Advance to an Adaptive Phase 2/3 Study

 

• Direct delivery of clofazimine to the lungs may provide a treatment option for nontuberculous mycobacterial (NTM) lung disease that potentially overcomes systemic toxicity and lessens side effects

• Paper published on clofazimine inhalation suspension demonstrates promising tolerability and toxicokinetics for treating pulmonary NTM infection

MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced clofazimine inhalation suspension (MNKD 101) will advance to an adaptive Phase 2/3 study. Additionally, a paper has been published in the American Society for Microbiology journal Antimicrobial Agents and Chemotherapy examining the potential for treatment of nontuberculous mycobacterial (NTM) infection through direct delivery of inhaled clofazimine to the lungs, overcoming the systemic toxicity witnessed in oral treatments.

Pulmonary NTM infection is recognized as a major global health concern due to its rising prevalence worldwide. It is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life. It is estimated that approximately 86,000-180,000 people in the U.S. alone are living with NTM lung disease, and it is on the rise growing 8% each year with women, the elderly, and those with underlying lung conditions at greatest risk. MNKD-101 has been designated by the FDA as both an orphan lung and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections.

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