By VETTAPHARMA reporter – Derek Roche: MannKind reported the completion of patient randomization in the U.S. Phase 1b INFLO-1 clinical trial and the enrollment of the first patient in the global Phase 2 INFLO-2 study evaluating nintedanib dry powder inhalation (DPI) in patients with idiopathic pulmonary fibrosis (IPF). The company said the milestones advance the program into a data-rich development period and support progression into mid-stage clinical evaluation.
The company expects to report data from the Phase 1b INFLO-1 study during the third quarter of 2026. The trial is evaluating the safety, tolerability, and pharmacokinetics of nintedanib DPI in patients with IPF.
INFLO-2 is a global, randomized, double-blind, placebo-controlled Phase 2 study designed to enroll approximately 210 participants across approximately 85 sites worldwide. Participants will be randomized to receive nintedanib DPI at 2 mg four times daily, 4 mg twice daily, or placebo for 12 weeks, followed by a 24-week open-label extension.
The primary objective of INFLO-2 is to assess safety and tolerability and identify an optimal dose for further development. Secondary objectives include evaluating the annualized rate of decline in forced vital capacity, a key measure of lung function in patients with IPF. The first patient in the study was enrolled in Windsor, Canada.
IPF is a chronic, progressive lung disease characterized by irreversible scarring of lung tissue that gradually impairs breathing and lung function. MannKind’s investigational DPI formulation utilizes its Technosphere inhalation technology to deliver nintedanib directly to the lungs. Nintedanib is currently available as an oral therapy for IPF.
For patients, inhaled delivery could potentially offer a new approach to administering nintedanib while maintaining direct drug delivery to the site of disease. The upcoming INFLO-1 data readout is expected to provide an early assessment of the safety and pharmacokinetic profile of the investigational therapy.
Commercially, the program represents an important pipeline opportunity for MannKind beyond its marketed diabetes and pulmonary disease products. Advancement into Phase 2 development and the anticipated clinical data in the second half of 2026 could provide important milestones for the company’s orphan lung disease portfolio.
Quick FAQs
What Is the Drug/Product/Asset?
Nintedanib DPI is an investigational dry powder inhalation formulation of nintedanib being developed by MannKind using its Technosphere inhalation technology for the treatment of idiopathic pulmonary fibrosis.
What Happened?
MannKind completed patient randomization in the Phase 1b INFLO-1 study and enrolled the first patient in the global Phase 2 INFLO-2 trial, advancing the nintedanib DPI program into mid-stage clinical development.
What Is the Study/Trial?
INFLO-1 is a U.S. Phase 1b study evaluating the safety, tolerability, and pharmacokinetics of nintedanib DPI in IPF patients. INFLO-2 is a global Phase 2 randomized, double-blind, placebo-controlled trial expected to enroll approximately 210 participants across about 85 sites worldwide.
What Is the Disease Condition?
Idiopathic pulmonary fibrosis is a chronic, progressive lung disease characterized by scarring of lung tissue that progressively reduces lung function and breathing capacity. An estimated 100,000 patients are affected in the United States.
What Were the Key Results?
No efficacy results were reported. MannKind announced completion of patient randomization in INFLO-1, enrollment of the first patient in INFLO-2, and stated that INFLO-1 data are expected in the third quarter of 2026.
Why Is This Important?
The milestones move nintedanib DPI into a data-rich period of development, with upcoming Phase 1b data and ongoing Phase 2 evaluation expected to generate evidence supporting future development of an inhaled treatment option for IPF.
