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Economy And The Numbers

MannKind's Nintedanib DPI Shows Favorable Safety In IPF Patients

By TajSabreen Ahamed   ✉  | Published:  | Google News Follow Us  | Join Us

MannKind Corporation (MNKD) announced positive topline results from its Phase 1b INFLO-1 study of nintedanib dry powder inhalation (DPI) in idiopathic pulmonary fibrosis (IPF), meeting its primary objective of demonstrating safety and tolerability.

The randomized, double-blind, placebo-controlled trial enrolled 27 patients across 10 U.S. sites and tested two multiple-ascending dose regimens over seven days. Results showed no serious adverse events, no gastrointestinal side effects, no bronchospasm, and no treatment discontinuations. Spirometry parameters were comparable between nintedanib DPI and placebo. Most patients experienced no cough, and when cough occurred, it was mild, transient, and resolved without intervention.

Chief Executive Officer Michael Castagna highlighted that across Phase 1a and 1b studies, more than 700 inhalations have been administered, including nearly 450 in IPF patients, with cough not posing a meaningful barrier to treatment.

The Phase 1a program in healthy volunteers has previously established a favorable safety profile, with rapid absorption and dose-proportional plasma concentrations consistent with deep-lung delivery.

MannKind is now advancing to its global Phase 2 INFLO-2 trial, which is actively enrolling patients. Additional data from INFLO-1 will be presented at a future conference.

MNKD has traded between $2.23 and $6.51 over the past year. The stock closed Tuesday's trading at $3.91, down 1.01%. In pre-market trading the stock is trading at $3.94, up 0.77%.

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