MannKind to Proceed With Phase 1 Nintedanib Dpi (Mnkd-201) Study for Pulmonary Fibrotic Diseases

• First-in-human study to evaluate safety, tolerability and pharmacokinetics (PK) in healthy volunteers
• Enrollment of first study participant anticipated in June 2024

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it will proceed with a first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF).

“We are pleased to progress nintedanib DPI which comes on the heels of furthering our Phase 3 study of Clofazimine Inhalation Suspension for nontuberculous mycobacterial (NTM) lung diseases,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “This puts two studies in motion by mid-year that will explore potential treatment options for patients living with serious lung diseases.”

The Phase 1 randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending dose (MAD) study will evaluate the safety, tolerability, and pharmacokinetics (PK) of nintedanib inhalation powder (MNKD-201) in healthy volunteers.

“Pulmonary fibrotic diseases – in particular IPF – are chronic, progressive diseases that result in loss of lung function and, for far too many, shortened lifespans,” said Dr. Wassim Fares, MSc, FCCP, Senior Vice President, Therapeutic Area Head, Orphan Lung Diseases of MannKind Corporation. “The team is eager and excited to initiate this study of MNKD-201 with results anticipated later this year, which will inform the next study of nintedanib DPI in patients with pulmonary fibrotic diseases.”

The Pulmonary Fibrosis Foundation indicates that there are over 250,000 Americans living with pulmonary fibrosis (PF) today, and 50,000 new cases are diagnosed each year. While it is unknown the number of people affected by IPF – the most common form of pulmonary fibrosis – the latest estimates indicate that 1 in 200 adults over the age of 70 are impacted in the United States. IPF is predominantly identified in men, but it is also increasing in women.

About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.