Avalyn to Highlight AURA-IPF Phase 2 Clinical Trial Design for AP02, Inhaled Nintedanib, at the European Respiratory Society International Congress 2025

CAMBRIDGE, Mass., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced a poster presentation highlighting its AURA-IPF Phase 2 clinical trial design for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis, at the European Respiratory Society (ERS) International Congress 2025. The congress will be held September 27 - October 1, 2025, in Amsterdam, Netherlands.

“We are excited to unveil the study design for AURA-IPF, our planned Phase 2 clinical trial of AP02 for the treatment of idiopathic pulmonary fibrosis, at this year’s ERS congress,” said Howard M. Lazarus, M.D., FCCP, Chief Medical Officer at Avalyn. "The AURA-IPF study design was informed by our successful Phase 1 studies of AP02, which demonstrated favorable tolerability, improved drug concentrations in the lungs and reduced systemic exposure compared to oral nintedanib, the current standard of care. These encouraging findings suggest that our inhaled delivery approach may provide enhanced therapeutic benefit with fewer side effects thus enabling long-term treatment. We look forward to advancing AP02 as rapidly as possible for patients who urgently need better treatment options."

Avalyn’s abstract is available on the ERS International Congress 2025 online program.

Poster Presentation Details:

Title: Inhalation Innovation: Phase 2 Study Design of Inhaled Nintedanib in the Treatment of Idiopathic Pulmonary Fibrosis
Authors: Michael Kreuter, Howard M. Lazarus, Debra Murwin, Elena Alhaja, Craig S. Conoscenti, Joyce Lee
Session: PS-37, Poster #: PA5139
Date and Time: September 30, 2025, between 8:00 a.m. - 9:30 a.m. CEST

About Avalyn Pharma
Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Investor Contact:
Alex Straus, THRUST
alex@thrustsc.com
ir@avalynpharma.com

Media Contact:
Kat Lippincott, Deerfield Group
kat.lippincott@deerfieldgroup.com
media@avalynpharma.com

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