other material
confidence high
sentiment neutral
materiality 0.65
Aligos: Phase 2 HBV interim – DSMB ups HBeAg- sample size to 100; FDA Fast Track granted
Aligos Therapeutics, Inc.
- DSMB recommended increasing HBeAg- cohort from 74 to 100 participants to optimize power; futility criteria not met.
- Study drugs well-tolerated; no viral breakthrough; safety data reviewed across all 174 enrolled participants.
- FDA granted Fast Track Designation for pevifoscorvir sodium based on 96-week Phase 1 data.
- Topline data from B-SUPREME study remains on track for 2027; enrollment in HBeAg- cohort expected by H2 2026.
- Aligos remains blinded to participant-level data; 103 enrolled in HBeAg+ cohort (Part 1a).