Clinical TrialJun 17, 2026, 08:11 AM
Avalyn Pharma Completes Enrollment in Phase 2b PPF Trial of AP01
AI Summary
Avalyn Pharma Inc. announced the completion of target enrollment for its Phase 2b MIST clinical trial investigating AP01 (inhaled pirfenidone) for patients with progressive pulmonary fibrosis (PPF). The trial enrolled 375 patients and is evaluating two doses of AP01 against a placebo, with the primary endpoint being lung function change at 52 weeks. The company anticipates reporting topline results in the second half of 2027, expressing optimism based on previous trial data and patient/investigator enthusiasm.
Key Highlights
- Avalyn Pharma completed target enrollment of 375 patients in its Phase 2b MIST trial for progressive pulmonary fibrosis (PPF).
- The MIST trial is evaluating AP01 (inhaled pirfenidone) at two doses (100 mg twice-daily, 50 mg twice-daily) against placebo.
- The primary endpoint of the MIST trial is the change from baseline in lung function (FVC) at 52 weeks.
- Topline clinical results from the MIST trial are expected in the second half of 2027.
- The trial design includes randomization of patients in a 2:1:2 ratio to AP01 100 mg, AP01 50 mg, and placebo cohorts.
- Enrollment was completed ahead of schedule due to strong enthusiasm from investigators and patients.
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