Avalyn Completes Target Enrollment in Phase 2b MIST Trial of AP01 (Inhaled Pirfenidone) for Patients with Progressive Pulmonary Fibrosis
Avalyn Pharma completed target enrollment of 375 patients in its Phase 2b MIST trial of inhaled pirfenidone AP01 for progressive pulmonary fibrosis, reaching this milestone ahead of schedule. The randomized, placebo-controlled trial is evaluating two dose levels with a primary endpoint of change in lung function (FVC) at 52 weeks, and topline data is anticipated in the second half of 2027.
Key figures
- Drug Name
- AP01
- Guidance
- Topline data expected in the second half of 2027
- Phase Of Trial
- Phase 2b
- Doses evaluated
- 100 mg twice-daily, 50 mg twice-daily
- Primary endpoint
- change from baseline in FVC at 52 weeks
- Target enrollment
- 375
- Randomization ratio
- 2:1:2
AI analysis
Red flags1 · Pro
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.