Avalyn Pharma Completes Enrollment of 375 Patients in Phase 2b AP01 Trial
AVLN•Avalyn Pharma has fully enrolled 375 patients in its global Phase 2b MIST trial of AP01 inhaled pirfenidone for progressive pulmonary fibrosis, with additional screened patients eligible for randomization. The company plans to report 12-month topline lung function results (FVC change) in the second half of 2027.
1. Enrollment Milestone Reached
Avalyn Pharma completed target enrollment of 375 patients in the global Phase 2b MIST trial of AP01 for progressive pulmonary fibrosis, with additional screened patients eligible for randomization over the next weeks. Strong investigator and patient demand enabled the company to meet this recruitment goal ahead of schedule.
2. Trial Design and Endpoints
The MIST trial is a randomized, double-blind, placebo-controlled study with three cohorts enrolled in a 2:1:2 ratio receiving AP01 100 mg twice-daily, 50 mg twice-daily or placebo. Its primary endpoint is change from baseline in forced vital capacity at 52 weeks.
3. Phase 1b Safety and Tolerability Data
In the preceding ATLAS Phase 1b study, AP01 demonstrated low rates of gastrointestinal and liver enzyme elevations and suggested a trend toward stability in lung function at the 100 mg dose. An ongoing open-label extension has reinforced AP01’s tolerability profile and potential to support longer treatment duration.
4. Next Steps and Reporting Timeline
Avalyn expects to report topline 12-month lung function results in the second half of 2027, which will assess AP01’s impact on preserving pulmonary capacity and improving quality of life. This milestone will inform potential late-stage development and regulatory strategy for inhaled pirfenidone.
