Avalyn Announces Initiation of Phase 1b Clinical Trial for AP02

Avalyn Pharma Inc., a biopharmaceutical company in the clinical stage that specializes in developing inhaled treatments for severe pulmonary diseases, has started a Phase 1b clinical trial to assess the safety, tolerability, and pharmacokinetics of AP02 (inhaled nintedanib) in healthy adult volunteers, using both single and multiple ascending doses.

AP02 is a new version of inhaled nintedanib designed specifically to focus on the lungs. During a Phase 1a trial of AP02 in healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF), AP02 was found to be well-tolerated with no serious adverse events (SAEs) reported and exhibited lower systemic exposure than oral nintedanib.

“The initiation of this AP02 study marks an important milestone for Avalyn, bringing us closer to delivering a potential new inhaled therapy to patients with pulmonary fibrosis, who are in urgent need of safe and effective treatments that they can tolerate for long-term management of their disease,” said Lyn Baranowski, CEO of Avalyn. “We’re excited to build on our completed Phase 1a study of AP02 and assess its pharmacokinetic profile to inform our future clinical studies. Our team has deep expertise in the development of inhaled therapies, and we’re intensely committed to advancing potentially transformational medicines for patients with life-threatening pulmonary diseases.”

The Phase 1b study, which is randomized, double-blind, and placebo-controlled, aims to assess the safety, tolerability, and pharmacokinetics of AP02 in healthy adult volunteers. The main focus of the research is the occurrence, rate, and intensity of adverse events (AEs). Other outcomes to be measured are various pharmacokinetic parameters assessed through blood and bronchoalveolar fluid samples.