AP01 for Idiopathic Pulmonary Fibrosis

(SAIL Trial)

This trial explores the long-term safety and tolerability of an inhaled medication called AP01 for individuals with lung conditions such as idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Participants will inhale AP01, a solution, twice daily to assess its tolerability over time. The trial is open to those who have completed a previous Avalyn-sponsored inhaled antifibrotic study. Ideal candidates have managed their condition without recent severe flare-ups or additional study medications. Participants will receive training on using the nebulizer device for the medication. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are in another clinical study or have taken another investigational drug recently.

Research has shown that AP01, an inhaled medication for treating fibrosis, has been safe in long-term studies. Patients have tolerated AP01 well for up to 240 weeks. While the oral form of a similar drug, pirfenidone, has been linked to some side effects, the inhaled AP01 appears safer. Ongoing studies continue to demonstrate AP01's safety and effectiveness compared to past data on the oral version. These findings suggest that the inhaled form might offer a gentler option for patients, with fewer side effects.¹²³⁴⁵

Unlike the standard treatments for Idiopathic Pulmonary Fibrosis (IPF), which include antifibrotic drugs like pirfenidone and nintedanib, AP01 offers a unique approach by potentially targeting the underlying mechanisms of the disease. Researchers are excited about AP01 because it may offer improved safety and tolerability over existing options, which often have challenging side effects. Additionally, AP01 is being explored for its long-term effects, which could provide sustained benefits for patients with this chronic condition.

Research has shown that AP01, an inhaled version of the drug pirfenidone, may help treat idiopathic pulmonary fibrosis (IPF), a lung disease. In earlier studies, AP01 proved more effective and easier to tolerate than the pill form of pirfenidone. Patients using AP01 experienced slower lung function decline and possibly lower death rates. The inhaled form also limits the drug's impact on the rest of the body, leading to fewer side effects outside the lungs. These findings suggest that AP01 could be an effective treatment option for people with IPF, with potentially fewer side effects.¹⁶⁷⁸⁹