Avalyn has initiated the AURA Phase II clinical trial assessing the efficacy and safety of AP02, inhaled nintedanib delivered through nebulisation, for idiopathic pulmonary fibrosis (IPF).
The first patient has been dosed in this randomised, double-blind, placebo-controlled trial that uses the PARI eFlow nebuliser to target medication delivery to the distal lung.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Earlier Phase I single-ascending and multiple-ascending dose studies in healthy adults and IPF patients showed tolerability and favourable safety at all tested doses.
These trials reported higher lung exposure with AP02 compared to oral dosing, while maintaining lower systemic levels.
The study is anticipated to enrol 160 IPF patients who have not previously received treatment and will compare two AP02 dose levels with a placebo. The primary goal is the change from baseline in forced vital capacity at week 12.
Key secondary and exploratory endpoints include time to disease progression, quantitative high-resolution computed tomography fibrosis scores, and quality-of-life metrics.
Avalyn CEO Lyn Baranowski said: “The initiation of our AURA Phase II clinical trial represents a significant step toward our goal of providing patients with pulmonary fibrosis with an urgently needed innovative treatment option that is well-tolerated and suitable for long-term use.
“AURA builds on our robust Phase I programme, where AP02 delivered via nebulisation demonstrated preferential exposure in the lungs at substantially lower doses relative to oral administration, with a favourable safety profile including no cough or bronchospasm following repeat dosing. Importantly, there was no diarrhoea reported, which is particularly notable given the profile of oral nintedanib.
“This indicates that inhaled delivery has the potential to achieve clinically meaningful lung exposure with signs supportive of a well-tolerated safety profile. We look forward to working closely with patients, investigators, and the broader pulmonary fibrosis community as we advance this important programme.”
