Avalyn Pharma Reports Results of Phase 1 Study of AP02 in Healthy Volunteers and Participants with Idiopathic Pulmonary Fibrosis
Seattle, March 30, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, today reported top-line results from the company’s Phase 1 trial for AP02 (inhaled nintedanib). AP02 was generally well tolerated, with no serious adverse events (SAEs) reported among the participants who were administered AP02.
“We were especially excited to see the tolerability results of AP02 in those participants with idiopathic pulmonary fibrosis (IPF), an underserved interstitial lung disease with survival rates between 3 and 5 years from diagnosis,” explained Lyn Baranowski, Avalyn’s CEO. “With a nebulized solution that is formulated to be easier to tolerate than the oral systemic therapies, we are hopeful that patients can stay on treatment longer, potentially improving outcomes.”
The open-label Phase 1 trial enrolled 38 participants, 32 of whom were healthy volunteers and 6 of whom had IPF. Four healthy volunteers ere administered oral nintedanib. Each of the 34 remaining participants were administered a single dose of AP02 (either 0.5 mg, 1 mg, or 2 mg) or placebo using an optimized eFlow Technology Nebulizer (PARI GmbH, Germany). Participants were monitored for safety, tolerability, and pharmacokinetics. The most common adverse events (AEs) observed in the study and deemed related to AP02 were cough and headache followed by nausea and dizziness. With the exception of one case of headache, which was moderate and resolved in an individual with IPF, all AEs were mild. Avalyn plans to present more detailed findings at a medical meeting later this year.
About Avalyn Pharma
General inquiries: Marc Schneebaum Chief Financial Officer, Avalyn Pharma Inc [email protected] Media: Aline Sherwood Scienta Communications [email protected]