CAMBRIDGE, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for treatment of life-threatening pulmonary diseases, today announced the initiation of its single-ascending dose (SAD) and multiple-ascending dose (MAD) Phase 1b clinical study evaluating the safety, tolerability, and pharmacokinetics of AP02 (inhaled nintedanib) in healthy adult volunteers. AP02 is a novel formulation of inhaled nintedanib optimized to target the lungs. In a completed Phase 1a trial of AP02 in healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF), AP02 was well-tolerated with no serious adverse events (SAEs) reported and had lower systemic exposure compared to 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 randomized, double-blind, placebo-controlled Phase 1b study will evaluate the safety, tolerability, and pharmacokinetics of AP02 in healthy adult volunteers. The primary endpoint for the study is the incidence, frequency, and severity of adverse events (AEs). Secondary endpoints include the measurement of multiple pharmacokinetic parameters as determined by samples of blood and bronchoalveolar fluid (BALF).

“My team and I are encouraged by the early clinical findings with AP02 and look forward to working with Avalyn on its continued development,” said Michael Kreuter, M.D., Professor of Pulmonology and Director of the Lung Center Mainz as Head of the Departments of Pneumology at the University Medical Center and the Marienhaus Clinik Mainz, Germany, and Avalyn’s Steering Committee Member for AP02. “There is a dire need for effective therapies with tolerability profiles that support longer treatment durations to improve outcomes for patients suffering from pulmonary fibrosis. I am hopeful that this Phase 1b study will further establish AP02’s potential as a novel inhaled therapy and offer a meaningful clinical benefit to patients.”

About Avalyn Pharma
Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, which has been assessed in 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety over existing therapies. Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis. For more information, please visit avalynpharma.com and follow us on LinkedIn.

Investor Contact:
Monique Allaire
THRUST Strategic Communications
monique@thrustsc.com