Avalyn completes Phase 2b MIST trial enrollment of 375 patients for inhaled pirfenidone in PPF; topline data H2 2027

Avalyn Pharma Inc.

Completed target enrollment of 375 patients in Phase 2b MIST trial of AP01 (inhaled pirfenidone) for progressive pulmonary fibrosis (PPF).
Trial is randomized, double-blind, placebo-controlled, evaluating two doses (50 mg and 100 mg BID) vs placebo; primary endpoint is change in FVC at 52 weeks.
Additional patients in screening remain eligible for randomization over next several weeks; enrollment completed ahead of schedule.
Topline 12-month clinical results expected in the second half of 2027.
AP01's tolerability profile may enable longer treatment duration, based on ATLAS Phase 1b and open-label extension data.

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