Aligos Advances HBV Drug Trial with Key Interim Analyses on Horizon
Event summary
- Aligos' Phase 2 B-SUPREME study for pevifoscorvir sodium in chronic HBV infection has enrolled 144 subjects globally, with topline data expected in 2027.
- First interim analysis of 36 HBeAg- participants (60% of cohort) completed in Q4 2025, with results expected in H1 2026.
- Second interim analysis of 55 HBeAg+ participants (50% of cohort) completed in January 2026, with results expected in H2 2026.
- Chief Medical Officer Hardean Achneck resigned; formal search for successor underway.
The big picture
Aligos' progress in the B-SUPREME study positions pevifoscorvir sodium as a potential best-in-class oral treatment for chronic HBV, a market with significant unmet needs. The interim analyses will be critical in assessing the drug's efficacy and safety profile, while the leadership transition adds a layer of operational risk. The study's success could bolster Aligos' pipeline and competitive standing in the HBV therapy space.
What we're watching
- Clinical Efficacy
- Whether pevifoscorvir sodium demonstrates superior antiviral activity compared to tenofovir disoproxil fumarate in interim analyses.
- Regulatory Pathway
- The pace at which Aligos advances pevifoscorvir sodium through the FDA, EMA, and NMPA regulatory pathways.
- Leadership Transition
- How the departure of the Chief Medical Officer may impact the B-SUPREME study's execution and timelines.