MannKind Achieves Key Clinical Milestones for Nintedanib DPI

MannKind announced key clinical execution milestones in the development of nintedanib DPI for idiopathic pulmonary fibrosis, or IPF, including the completion of patient randomization in the U.S. Phase 1b INFLO-1 clinical trial and enrollment of the first patient in the global Phase 2 INFLO-2 study. These milestones mark the advancement of the nintedanib DPI program and support its progression into mid-stage clinical evaluation. MannKind expects to report data from the INFLO-1 study in the Q3, which is expected to provide an initial clinical assessment of safety, tolerability, and pharmacokinetics in patients with IPF. INFLO-2 is expected to enroll approximately 210 participants across approximately 85 sites worldwide. The first patient was enrolled in Windsor, Canada. IPF is a chronic, progressive lung disease characterized by irreversible fibrosis and declining lung function. Despite available therapies, the disease remains associated with substantial morbidity and mortality. Nintedanib, currently approved as an oral therapy for IPF, has demonstrated the ability to slow disease progression but can be associated with systemic side effects that may limit tolerability, treatment persistence, and the ability to use combination therapies. Nintedanib DPI leverages MannKind's Technosphere dry powder inhalation technology to deliver nintedanib directly to the deep lung, with the goal of achieving therapeutic concentrations at the site of disease while reducing systemic exposure. MannKind has developed two FDA-approved dry powder inhalation therapies utilizing its proven Technosphere formulation technology, with clinical data demonstrating less than 3% discontinuation due to cough. A randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of nintedanib DPI in patients with IPF followed by an open-label extension. The global study will randomize participants in a 1:1:1 ratio to receive either nintedanib DPI or placebo for 12 weeks, followed by a 24-week open-label extension in which all participants may receive active treatment. The primary objective of the study is to assess safety and tolerability and to determine an optimal dose of nintedanib DPI. INFLO-1 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib DPI in patients with IPF. The U.S. trial consists of multiple ascending doses with the primary objective to evaluate safety, tolerability and pharmacokinetics of nintedanib DPI compared to placebo in patients with IPF.