In April 2025, Avalyn Pharma announced plans to advance its AP02 nintedanib inhalation solution into a Phase 2 trial in patients with idiopathic pulmonary fibrosis. Avalyn has now announced the initiation of the Phase 2 AURA trial, which is expected to enroll 160 IPF patients who will receive one of two dose levels of AP02 delivered via PARI‘s eFlow nebulizer or nebulized placebo.
In July 2025, the company said that it had raised $100 million to support continued development of AP02 and other inhaled drugs for the treatment of pulmonary fibrosis, including AP01 pirfenidone and AP03 pirfenidone / nintedanib. In October 2025, Avalyn announced the appointments of Jill Denning as Senior VP, Clinical Development Operations, and Kimberley Cummings as Senior VP, Regulatory Affairs.
Avalyn CEO Lyn Baranowski commented, “The initiation of our AURA Phase 2 clinical trial represents a significant step toward our goal of providing patients with pulmonary fibrosis with an urgently needed innovative treatment option that is well-tolerated and suitable for long-term use. AURA builds on our robust Phase 1 program, where AP02 delivered via nebulization demonstrated preferential exposure in the lungs at substantially lower doses relative to oral administration, with a favorable safety profile including no cough or bronchospasm following repeat dosing. . . . We look forward to working closely with patients, investigators, and the broader pulmonary fibrosis community as we advance this important program.”
Read the Avalyn Pharma press release
