MannKind Successfully Completes Phase 1 Trial of Nintedanib DPI for Pulmonary Fibrotic Diseases

Core Insights - MannKind Corporation has successfully completed its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF) [1][2] - The study demonstrated that nintedanib DPI was safe and well tolerated, with no typical adverse events associated with oral nintedanib reported [2][3] - The company plans to meet with the FDA in the first half of 2025 to discuss the Phase 1 trial results and the proposed late-stage development program for MNKD-201 [1][2] Study Results - Nintedanib DPI was shown to be safe and well tolerated in healthy volunteers, with no gastrointestinal or neurologic adverse events reported [2][3] - Mild and transient adverse events included cough and a drop in FEV-1, which were not dose-dependent and did not show a pattern of recurrence [2][3] - The Phase 1 study was a single-site, randomized, placebo-controlled trial involving 40 healthy adult participants, focusing on safety, tolerability, and pharmacokinetics [2][3] Implications for Treatment - The findings support the advancement of nintedanib DPI as a potential treatment for patients with IPF, a disease with limited treatment options [2][3] - The delivery of a dry powder formulation directly to the lungs may reduce common adverse effects associated with oral nintedanib [3] - Preclinical chronic toxicology studies did not show adverse findings, further supporting the development of nintedanib DPI [3] Industry Context - Over 250,000 Americans are currently living with pulmonary fibrosis, with 50,000 new cases diagnosed each year [4] - IPF is one of the most common forms of pulmonary fibrosis, predominantly affecting men but increasingly seen in women [4] - MannKind Corporation focuses on developing innovative inhaled therapeutic products to address serious unmet medical needs in endocrine and orphan lung diseases [5][6]