Danbury-headquartered MannKind Corp. (NASDAQ: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced the U.S. Patent and Trademark Office issued a new patent (No. 11,793,808) covering the company’s clofazimine inhalation suspension (MNKD-101), which is under development for the potential treatment of nontuberculous mycobacterial (NTM) lung disease.
Pulmonary NTM infection 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. are living with NTM lung disease. According to Mannkind, pulmonary NTM infection is 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 drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. The patent will expire on June 8, 2039.
“We believe this patent represents important protection for our lead pipeline asset, MNKD-101, that could potentially improve therapy for a disease that is increasingly on the rise globally,” said Dr. Michael Castagna, CEO of MannKind. “Patients living with NTM typically rely on a series of drug treatments that often may be associated with severe side effects. Early data for MNKD-101 is promising as it suggests rapid and targeted delivery of clofazimine deep into the lung has the potential to be better tolerated.”
