Avalyn Pharma has published data from its Phase 1b ATLAS study evaluating the safety of AP01 nebulized pirfenidone in patients with idiopathic pulmonary fibrosis over 72 weeks. In the article, the authors report that treatment-related adverse events were mild-to-moderate and less frequent than side effects associated with oral pirfenidone. They also reported that forced vital capacity (FVC) stabilized for most patients taking a 100 mg dose twice daily, with a mean FVC change of -0.4% at week 48.
The study was initiated in June 2019 and enrolled 91 patients with IPF to receive twice daily doses of AP01 inhalation solution delivered via a PARI eFlow nebulizer at either 50 mg or 100 mg. In October 2020, the company announced that, based on data at 24 weeks, it would continue with the higher dosage only. Avalyn says that 54 patients continued through week 72, and 41 of those continued into an open-label extension.
Avalyn CEO Lyn Baranowski commented, “While oral pirfenidone has the potential to improve lung function by reducing fibrosis, its utility is limited by its poor tolerability profile. Although the ATLAS study’s primary endpoint was safety, secondary measures of efficacy showed a trend towards disease stabilization in participants with IPF who administered high-dose AP01. Based on this data, we believe AP01 has the potential to meet or exceed the efficacy of oral pirfenidone without the systemic toxicities that limit its adoption. We are eager to explore this hypothesis in a larger, controlled efficacy trial that we plan to begin later this year.”
Read the Avalyn Pharma press release.
