Clinical TrialJul 29, 2026, 06:33 AM
MannKind's INFLO-1 Phase 1b Nintedanib DPI Trial Shows Positive Results
AI Summary
MannKind Corporation announced positive topline results from its INFLO-1 Phase 1b study evaluating nintedanib dry powder inhalation (DPI) for idiopathic pulmonary fibrosis (IPF). The study met its primary objective, demonstrating the drug was generally safe and well-tolerated, with no serious adverse events or discontinuations. The company is actively enrolling patients in its global Phase 2 INFLO-2 study to further evaluate safety, tolerability, and efficacy.
Key Highlights
- INFLO-1 Phase 1b study met primary objective, showing nintedanib DPI was safe and well-tolerated.
- No serious adverse events, bronchospasm, or study drug discontinuations were reported in INFLO-1.
- 90% of patients in INFLO-1 experienced no (60%) or mild (30%) cough.
- Nearly 450 total inhalations of nintedanib DPI were administered to IPF patients in INFLO-1.
- Global Phase 2 INFLO-2 trial is actively enrolling approximately 210 IPF patients worldwide.
- INFLO-2 will assess safety, tolerability, and potential efficacy signals, including FVC decline.
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