The company said the study found no serious adverse events, no bronchospasm or diarrhea, and is continuing to enroll a global Phase 2 trial in idiopathic pulmonary fibrosis.
MannKind Corporation said its Phase 1b INFLO-1 trial met its primary objective, showing that nintedanib dry powder inhalation was generally safe and well tolerated in patients with idiopathic pulmonary fibrosis (IPF). The randomized, double-blind, placebo-controlled study enrolled 27 patients across 10 U.S. sites and tested two multiple-ascending dose regimens over seven days. The company reported no serious adverse events, no drug-related gastrointestinal side effects including diarrhea, nausea and vomiting, no bronchospasm events, no treatment discontinuations or dose reductions, and no differences in spirometry (lung function breathing test) parameters versus placebo. It also said 90% of patients had no cough or only mild cough, with cough events described as predominantly mild, transient and resolved. MannKind added that roughly 450 inhalations have been administered in patients with IPF and more than 700 across its Phase 1a and Phase 1b studies combined. The company is now actively enrolling its global Phase 2 INFLO-2 trial, which is expected to include about 210 participants at about 85 sites worldwide and will assess safety, tolerability and efficacy, including forced vital capacity (FVC) as a key lung function measure.