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

Core Viewpoint - MannKind Corporation is advancing its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF), with participant enrollment expected to begin in June 2024 [1][2]. Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products and devices aimed at addressing serious unmet medical needs in endocrine and orphan lung diseases [4]. - The company utilizes dry-powder formulations and inhalation devices to deliver medications effectively to the lungs, targeting conditions such as diabetes, nontuberculous mycobacterial lung disease, pulmonary fibrosis, and pulmonary hypertension [4]. Clinical Study Details - The Phase 1 study will be randomized, double-blind, placebo-controlled, and will assess the safety, tolerability, and pharmacokinetics of nintedanib inhalation powder in healthy volunteers [2]. - Results from this study are anticipated later in the year, which will inform subsequent studies involving patients with pulmonary fibrotic diseases [3]. Market Context - There are over 250,000 Americans currently living with pulmonary fibrosis, with approximately 50,000 new cases diagnosed annually [3]. - The prevalence of idiopathic pulmonary fibrosis is significant, with estimates suggesting that 1 in 200 adults over the age of 70 in the U.S. are affected [3].