MannKind hits dual trial milestones for inhaled lung fibrosis drug

MannKind (NASDAQ:MNKD) achieved key clinical development milestones for its investigational lung disease therapy, pushing its dry powder formulation of nintedanib further into mid-stage clinical testing.

The company announced the completion of patient randomization in its U.S.-based Phase 1b trial alongside the enrollment of the first patient in its global Phase 2 study.

The advancements focus on the evaluation of nintedanib DPI (Dry Powder Inhaler) as a targeted treatment for idiopathic pulmonary fibrosis (IPF), a chronic and progressive respiratory condition characterized by irreversible lung scarring.

By shifting delivery from standard oral administration to an inhaled format, the company aims to alter how the active drug interacts with a patient's body.

MannKind expects to report top-line data from the U.S. Phase 1b study, dubbed INFLO-1, in the third quarter of 2026.

This initial trial is designed to provide primary assessments regarding the safety, tolerability, and pharmacokinetic profile of the inhaled compound within an active patient population.

Simultaneously, operations have commenced for the global Phase 2 study, known as INFLO-2, following the enrollment of its first clinical participant.

This mid-stage trial is designed to scale up clinical evaluation significantly, planning to enroll approximately 210 participants across roughly 85 clinical sites worldwide.

The clinical program leverages MannKind’s proprietary Technosphere dry powder inhalation technology.

The platform is engineered to deliver the antifibrotic medication directly into the deep tissues of the lungs.

If successful, local delivery could achieve the necessary therapeutic effects directly at the site of the disease while potentially reducing systemic exposure, a major factor that often limits the long-term tolerability and adherence of existing oral treatments for pulmonary fibrosis.