Nintedanib Dpi (Mnkd-201) - (INFLO-1)

June 3, 2026: MannKind Corporation (NASDAQ: MNKD) announced clinical execution milestones for inhaled nintedanib dry powder inhaler (DPI; MNKD-201) in idiopathic pulmonary fibrosis (IPF). The company completed patient randomization in the U.S. Phase 1b INFLO-1 randomized, double-blind, placebo-controlled multiple ascending dose study and enrolled the first patient in the global Phase 2 INFLO-2 trial (first enrollment in Windsor, Canada).

Upcoming catalyst: MannKind expects a Phase 1b INFLO-1 data readout in Q3 2026, intended to provide an initial assessment of safety, tolerability, and pharmacokinetics in IPF patients.

INFLO-2 design: approximately 210 participants across ~85 sites worldwide; 1:1:1 randomization to nintedanib DPI 2 mg four times daily, 4 mg twice daily, or placebo for 12 weeks, followed by a 24-week open-label extension. Primary objectives are safety/tolerability and dose optimization; secondary objectives include a potential efficacy signal such as annualized rate of decline in forced vital capacity (FVC), plus other disease and patient-reported endpoints and pharmacokinetics.