Posted by Michael Wonder on 15 Apr 2026
Aligos Therapeutics announces first interim analysis results from the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection and grant of FDA fast track designation
14 April 2026 - Aligos Therapeutics today announced the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus (HBV) infection for the Part 2a (HBeAg- cohort) where the independent Data Safety Monitoring Review Board (DSMB) has recommended continuation of the study with an increase in sample size for this cohort in order to optimize statistical powering; futility criteria for the cohort was not met.
Additionally, Aligos announced that the US FDA has granted fast track designation to pevifoscorvir sodium, a potential best/first-in-class capsid assembly modulator under investigation for the treatment of chronic hepatitis B virus infection.
The study design for the Phase 2 B-SUPREME study includes pre-specified sample size re-estimations for both Parts 1a and 2a to ensure sufficient power to demonstrate a statistically significant treatment effect at the primary outcome.
