Avalyn Pharma Inc., a clinical-stage biopharmaceutical company developing inhaled therapies for life-threatening pulmonary diseases, announced it will present the AURA-IPF Phase 2 clinical trial design for AP02, inhaled nintedanib, at the European Respiratory Society International Congress 2025. The presentation will take place September 30, 2025, in Amsterdam, Netherlands.
Phase 1 Results Support Advanced Development
The AURA-IPF study design builds upon 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 for idiopathic pulmonary fibrosis (IPF).
"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," said Howard M. Lazarus, M.D., FCCP, Chief Medical Officer at Avalyn. "These encouraging findings suggest that our inhaled delivery approach may provide enhanced therapeutic benefit with fewer side effects thus enabling long-term treatment."
Addressing Treatment Limitations in Pulmonary Fibrosis
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 is designed to tackle the underlying pathophysiology of pulmonary fibrosis at its source by reducing systemic exposure and delivering medication directly to the site of disease.
Broader Pipeline Development
Beyond AP02, Avalyn is developing AP01, 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.
Conference Presentation Details
The poster presentation, titled "Inhalation Innovation: Phase 2 Study Design of Inhaled Nintedanib in the Treatment of Idiopathic Pulmonary Fibrosis," will be presented by authors Michael Kreuter, Howard M. Lazarus, Debra Murwin, Elena Alhaja, Craig S. Conoscenti, and Joyce Lee during Session PS-37, Poster #PA5139, on September 30, 2025, between 8:00 a.m. - 9:30 a.m. CEST.
