According to Avalyn Pharma, Phase 1 trials of AP02 inhaled nintedanib demonstrated that all dose levels of the nebulized formulation were safe and well tolerated and that the company now plans to advance AP02 into a Phase 2 trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn said that it will present top-line data from the Phase 1 studies at the upcoming ATS 2025 International Conference.
The company’s AP01 pirfenidone inhalation solution is already in Phase 2 development. A Phase 2 trial of AP01 in patients with progressive pulmonary fibrosis (PPF) was initiated in 2024 and is ongoing.
Avalyn CEO Lyn Baranowski commented, “We are excited to complete this innovative set of clinical trials for AP02, where we assessed lung exposure in both studies of the inhaled compared to oral nintedanib. Through its enhanced drug delivery directly to the lungs, our approach allows us to address the underlying pathophysiology of the disease and positions AP02 as a potential future standard-of-care for patients with IPF.”
Read the Avalyn Pharma press release
