MannKind to Proceed With Phase 1 Nintedanib DPI Study for Pulmonary Fibrotic Diseases
MannKind Corporation recently announced 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.
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. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram.
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