Avalyn Presents Clinical Data on AP01 for Pulmonary Fibrosis, Including Long-Term Efficacy and Imaging Biomarker Data, at ATS 2024
CAMBRIDGE, Mass., May 20, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Avalyn), a clinical-stage biopharmaceutical company focused on development of inhaled therapies for treatment of life-threatening pulmonary diseases, today presented clinical data for AP01, its novel formulation of inhaled pirfenidone, for the treatment of pulmonary fibrosis, supporting the Company’s planned Phase 2b trial in patients with progressive pulmonary fibrosis (PPF). Analysis from Avalyn’s ongoing ATLAS open-label extension study demonstrated that treatment with AP01 stabilized forced vital capacity (FVC) in patients with both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), with enhanced safety and tolerability compared to oral pirfenidone. Furthermore, findings from post-hoc analyses examining disease progression and Brainomix’s e-Lung biomarker scores support the Company’s selected dosing of 100 mg twice-daily and 50 mg twice-daily in the planned Phase 2b study.
- The data were presented in multiple poster presentations and featured events during the 2024 American Thoracic Society (ATS) International Conference held May 17-22, 2024, in San Diego, CA.
- “Having dedicated decades to treating patients with respiratory diseases, I’ve seen firsthand the pressing need for new treatments.
- Our excitement stems from the long-term data with AP01 that shows treatment of patients out to nearly four years, surpassing the average survival rates for patients with progressive disease.
- These data support Avalyn’s selection of AP01 100 mg twice-daily and 50 mg twice-daily for the Company’s planned Phase 2b clinical trial.