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

July 29, 2026: MannKind Corporation (NASDAQ: MNKD) reported positive topline results from INFLO-1, a Phase 1b randomized, double-blind, placebo-controlled study of nintedanib dry powder inhalation (DPI; MNKD-201) in idiopathic pulmonary fibrosis (IPF). The trial met its primary objective, showing nintedanib DPI was generally safe and well tolerated. In 27 IPF patients across 10 U.S. sites receiving multiple-ascending doses over seven days, there were no serious adverse events, no bronchospasm, no drug-related GI side effects (diarrhea/nausea/vomiting), and no treatment discontinuations, dose reductions, or spirometry differences versus placebo (empty cartridges). Cough was mostly absent (90% none or mild) and events were predominantly mild, transient, and resolved.

MannKind said more than 700 total inhalations have been administered across Phase 1a/1b, including ~450 in IPF patients; additional data will be presented at a future conference.

Upcoming/ongoing catalyst: the global Phase 2 INFLO-2 trial is actively enrolling (~210 participants at ~85 sites) to evaluate 12-week dosing (2 mg QID or 4 mg BID) versus placebo with a 24-week open-label extension; endpoints include safety/tolerability and efficacy signals such as annualized FVC decline. Management will discuss results on a July 29, 2026 webcast at 4:30 p.m. ET.