GlobeNewswire·Apr 14, 2026, 4:05 PM ET

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

Aligos Therapeutics received FDA Fast Track Designation for pevifoscorvir sodium for the treatment of chronic hepatitis B virus (HBV) infection.
The independent Data Safety Monitoring Review Board recommended increasing the Phase 2 B-SUPREME study Part 2a (HBeAg-) cohort sample size from 74 to 100 participants to optimize statistical powering.
Futility criteria for the HBeAg- cohort were not met, allowing the study to continue.
Study drugs were well-tolerated with no clinically concerning safety abnormalities or viral breakthroughs observed among the 174 participants reviewed.
Completion of enrollment for the HBeAg- cohort is expected in the second half of 2026, with topline data on track for 2027.
Pevifoscorvir sodium is a potential best/first-in-class oral capsid assembly modulator (CAM-E) derived from Emory University research.
The FDA Fast Track Designation was supported by Phase 1 data showing sustained reductions in HBV viral markers over 96 weeks.
The Phase 2 B-SUPREME study is a randomized, double-blind, active-controlled trial evaluating pevifoscorvir sodium against tenofovir disoproxil fumarate in approximately 200 untreated HBV patients.