Avalyn Publishes Phase 1 Data Supporting Lung-Targeted AP02 In Lung Disease

(RTTNews) - Avalyn Pharma Inc. (AVLN) reported that Respiratory Research has published detailed results from two Phase 1 clinical trials of AP02, a nebulized formulation of nintedanib, in healthy volunteers and patients with idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis, or IPF, is a chronic progressive lung disease characterized by scarring of lung tissue, which gradually impairs breathing and reduces lung function.

AP02 is designed to deliver nintedanib directly to the lungs while limiting systemic exposure.

The two randomized Phase 1 studies evaluated its safety, tolerability and pharmacokinetics, including lung and systemic drug exposure.

In the first randomized Phase 1 study, AP02 was evaluated at single ascending doses of up to 2 mg in 32 healthy volunteers and six patients with IPF. A separate cohort of four healthy volunteers received the approved 150 mg oral dose of nintedanib.

The second study evaluated single and multiple ascending doses of AP02, up to 8 mg twice daily for seven days, in healthy volunteers.

The pharmacokinetic data showed 10- to 56-fold lower systemic exposure with AP02 across multiple-dose cohorts compared with the mean steady-state exposure associated with the approved 150 mg oral dosage.

At the 4 mg dose, AP02 produced approximately 26-fold higher predicted nintedanib peak concentration and overall exposure in epithelial lining fluid compared with oral nintedanib.

According to Avalyn, AP02 was generally well tolerated across both studies, with no serious adverse events and no treatment-related adverse events leading to withdrawal was observed.

Based on the Phase 1 findings, Avalyn advanced AP02 into the AURA Phase 2 trial, a randomized, double-blind, placebo-controlled study evaluating two twice-daily doses in 160 patients with IPF. The 12-week trial is assessing safety and efficacy, with topline data expected in late 2027.

AVLN closed Monday's trade at $31.62, up 0.32%.