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

• Received FDA Fast Track Designation for pevifoscorvir sodium for the treatment of chronic hepatitis B virus infection
• HBeAg- cohort sample size increased to optimize powering; futility criteria not met
• Study drugs were well-tolerated by participants
• Topline data expected in 2027, guidance remains unchanged

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., April 14, 2026 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, 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 United States Food and Drug Administration (FDA) has granted Fast Track Designation to pevifoscorvir sodium, a potential best/first-in-class capsid assembly modulator (CAM-E) under investigation for the treatment of chronic hepatitis B virus (HBV) infection.

Interim Analysis

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 endpoint. The first pre-specified interim analysis of the Phase 2 B-SUPREME study was performed after approximately 60% of HBeAg- participants (N=34, Part 2a) reached Week 12 or later. In addition, safety data was reviewed for all participants enrolled in the study (N=174) at the time the interim analysis was performed.

Findings from the first interim analysis include:

• The DSMB recommended increasing the sample size of Part 2a from 74 currently enrolled to 100 participants. A futility analysis was performed; the prespecified futility criteria was not met, per the statistical analysis plan.

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