- Generally well-tolerated with no serious adverse events, bronchospasm or diarrhea; no study drug discontinuations
- 90% of patients had no [60%] or mild [30%] cough
- ~450 total inhalations administered in patients with IPF
- Global Phase 2 INFLO-2 trial actively enrolling patients
- Conference call and webcast scheduled for July 29 at 4:30 p.m. ET
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a biopharmaceutical company focused on developing innovative, patient-centric therapies for chronic diseases, today announced positive topline results from INFLO-1, its Phase 1b randomized, double-blind, placebo-controlled study evaluating nintedanib dry powder inhalation (DPI) in patients with idiopathic pulmonary fibrosis (IPF).
The study met its primary objective, demonstrating that nintedanib DPI was generally safe and well tolerated in patients with IPF. The Phase 1b study enrolled 27 patients across 10 U.S. sites and evaluated two multiple-ascending dose regimens of nintedanib DPI administered over seven days.
INFLO-1 Topline Results
Key findings from the study included:
- No serious adverse events
- No drug-related gastrointestinal side effects (i.e., diarrhea, nausea, vomiting)
- No bronchospasm events
- No treatment discontinuations or dose reductions
- No differences in spirometry parameters between nintedanib DPI and placebo (empty cartridges)
- Most patients experienced no cough; reported cough events were predominantly mild, transient and resolved
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