Avalyn completes enrollment in Phase 2b pulmonary fibrosis trial of AP01

Avalyn Pharma Inc. announced on August 12, 2026 that it had enrolled beyond its target of 375 patients, ending with 398 patients randomized across three treatment cohorts¹ in its global Phase 2b trial called MIST. The study is a randomized, double-blind, placebo-controlled trial testing two doses of AP01 given twice daily in patients with progressive pulmonary fibrosis, running 52 weeks with a primary endpoint of change in forced vital capacity¹. Avalyn said topline data are anticipated in the second half of 2027¹.

The company also plans to present two posters at the European Respiratory Society Congress in Barcelona in September 2026, one on modeling of AP01 distribution in lung tissue in healthy and idiopathic pulmonary fibrosis lungs, and another on incorporating patient perspectives into trial design¹.

For its second program, AP02, an inhaled formulation of nintedanib, enrollment in the Phase 2 trial known as "AURA" was initiated in the first quarter of 2026¹. Avalyn described AURA as a randomized, double-blind global study testing two doses of AP02 dosed twice daily in idiopathic pulmonary fibrosis patients, enrolling 160 patients over 12 weeks with FVC as the safety and efficacy measure¹, with topline data expected in late 2027¹.

On its combination candidate, AP03, pairing inhaled pirfenidone and nintedanib, Avalyn said a Phase 1 study remains on track to begin by the end of 2026¹.

Turning to finances, Avalyn ended the quarter with $413.5 million in cash, cash equivalents and marketable securities as of June 30, 2026, which includes about $316.6 million in net proceeds from its May 2026 initial public offering, and said this is projected to fund operations into 2029¹.