An Open-Label Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are serious lung conditions where the lungs gradually become scarred and stiff, making breathing increasingly difficult over time. While some treatments can slow progression, there is no cure. Avalyn Pharma is developing an inhaled antifibrotic medication called AP01, which is designed to deliver the drug directly to the lungs to reduce scarring. This open-label extension study allows participants who have already completed an earlier Avalyn-sponsored clinical trial of AP01 to continue receiving the treatment until the drug is approved, the study ends, or they choose to withdraw. This type of study is important for collecting longer-term safety and tolerability data and ensuring that participants who responded to treatment are not left without access between trials. You are eligible if you previously completed the full treatment period of an Avalyn-sponsored inhaled antifibrotic study and were not permanently discontinued. Women of childbearing potential must agree to use contraception throughout and for 90 days after the last dose. People who had an acute exacerbation of their lung condition in the last 3 months are not eligible.