Aligos Therapeutics Raises Phase 2 HBV Trial Sample to 100, Gains FDA Fast Track
Aligos Therapeutics’ DSMB recommended increasing its Phase 2 B-SUPREME HBeAg- cohort sample size from 74 to 100 participants after the interim analysis showed futility criteria were not met and safety remained favorable. The FDA granted Fast Track designation to pevifoscorvir sodium, maintaining a 2027 topline data timeline.
1. Interim Analysis Outcomes
The independent Data Safety Monitoring Board reviewed safety data for all 174 participants and recommended increasing the HBeAg- cohort sample from 74 to 100 to optimize statistical power after the interim futility criteria was not met. The study drugs were well tolerated, with no concerning laboratory or ECG abnormalities and no observed viral breakthroughs.
2. FDA Fast Track Designation
The FDA granted Fast Track designation to pevifoscorvir sodium for chronic hepatitis B treatment, recognizing its potential as a best-in-class capsid assembly modulator. This status enables more frequent FDA interactions and may allow rolling review, accelerated approval, or priority review if criteria are met.
3. Study Timeline and Next Steps
Enrollment in the HBeAg- cohort is expected to complete in the second half of 2026, with a second interim analysis also slated for that period. Topline data for the Phase 2 B-SUPREME study remains on track for release in 2027, as Aligos remains blinded to participant-level data.