Apr. 14 at 8:12 PM
$ALGS Aligos reports first interim analysis of B-SUPREME study, fast track designation
Aligos Therapeutics announced the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection for the Part 2a where the independent Data Safety Monitoring Review Board 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 FDA has granted fast track designation to pevifoscorvir sodium, a 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 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. 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. The study drugs were well-tolerated with no clinically concerning laboratory, physical examination, vital sign, or ECG abnormalities. No viral breakthrough related to study drugs has been observed in the study to date. Aligos remains blinded to participant-level data. Completion of enrollment in the HBeAg- cohort is expected in the second half of 2026. Currently, there are 74 participants enrolled in the HBeAg- cohort, with 103 participants enrolled in the HBeAg+ cohort. Topline data remains on track for 2027.