Clinical TrialJun 17, 2026, 08:01 AM
Avalyn completes target enrollment in Phase 2b MIST trial for PPF
AI Summary
Avalyn Pharma Inc. announced the completion of target enrollment of 375 patients in its Phase 2b MIST clinical trial for AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF). This milestone was achieved ahead of schedule, underscoring the demand for new treatment options. The trial evaluates the safety and efficacy of two doses of AP01, with topline data expected in the second half of 2027. The company believes AP01's tolerability profile may enable patients to remain on treatment longer, potentially preserving lung function and improving quality of life.
Key Highlights
- Completed target enrollment of 375 patients in the Phase 2b MIST clinical trial for AP01.
- The MIST trial evaluates AP01 (inhaled pirfenidone) for progressive pulmonary fibrosis (PPF).
- Patients were randomized into AP01 100 mg twice-daily, AP01 50 mg twice-daily, and placebo cohorts.
- The primary endpoint is the change from baseline in forced vital capacity (FVC) at 52 weeks.
- Topline data from the MIST trial is expected in the second half of 2027.
- Enrollment was completed ahead of schedule due to strong investigator and patient enthusiasm.
- AP01 demonstrated low rates of side effects in the ATLAS Phase 1b study.
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