MannKind reports results from Phase 1 study of nintedanib DPI

MannKind (MNKD) announced the successful completion of its first-in-human Phase 1 study of nintedanib DPI, or MNKD-201, for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis, or IPF. Nintedanib DPI was shown to be safe and well tolerated in healthy volunteers with the tested doses and study duration. Participants did not experience typical adverse events seen with oral nintedanib; specifically, no GI or neurologic adverse events, or AEs, were reported. Two types of AEs noted – cough and drop in FEV-1: these AEs were mild, transient, and fully recovered; these AEs were not dose-dependent and there was no pattern of recurrence or worsening with repeated dosing; no bronchospasm, wheezing, other symptoms, or change in vital signs were reported. No serious adverse events or study drug discontinuation. The completed Phase 1 was a single-site, randomized, placebo-controlled, single- and multiple-ascending dose study in healthy adult participants. The primary objective of the study was to evaluate the safety and tolerability of nintedanib DPI. The secondary study objective was to evaluate the pharmacokinetics of MNKD-201. Additionally, the preclinical chronic toxicology study did not show any adverse findings and supports further development of nintedanib DPI.