Aligos Therapeutics announced positive first interim analysis of Phase 2 B-SUPREME study for pevifoscorvir sodium in chronic HBV, with DSMB recommending HBeAg- cohort continuation and sample size increase to 100, plus FDA Fast Track Designation.
Key takeaways
DSMB recommended continuing Phase 2 B-SUPREME Part 2a (HBeAg- cohort) after interim analysis at ~60% enrollment (N=34), increasing sample size from 74 to 100 to optimize powering.
Futility criteria not met for HBeAg- cohort; study drugs well-tolerated with no safety concerns or viral breakthroughs observed.
FDA granted Fast Track Designation to pevifoscorvir sodium for chronic HBV treatment, supported by Phase 1 data showing viral marker reductions.
Enrollment completion for HBeAg- cohort expected in H2 2026; topline data on track for 2027.
Currently 74 participants in HBeAg- cohort and 103 in HBeAg+ cohort.