Aligos' hepatitis B pill clears first futility check, DSMB expands cohort
The HBeAg-negative interim analysis avoided stopping for futility, prompting a DSMB-recommended enrollment expansion, while the HBeAg-positive interim central to B-SUPREME's design is still ahead in H2 2026.
Executive Summary
- The first prespecified interim look at Aligos Therapeutics' hepatitis B pill cleared a futility check, and the study's independent safety monitors responded by recommending a larger cohort rather than a stop.
- A second interim analysis, this time in the viral phenotype that carries a tougher suppression bar, is still coming later this year and will be the first real read on whether the drug's effect holds across both patient populations the trial was built to test.
- The drug's target has not been established in available data, so its competitive position rests on modality and trial design rather than a claim to mechanistic novelty; no head-to-head comparator has yet been positioned against it in this population.
- Operational execution looks intact through the safety and futility checkpoint, but the study's actual antiviral suppression endpoints, the numbers that would decide whether this monotherapy approach beats or matches the standard oral nucleotide, remain unread in either cohort.
The readout so far
B-SUPREME (NCT06963710) is a randomized, double-blind, active-controlled Phase 2 study testing pevifoscorvir sodium (ALG-000184) monotherapy against tenofovir disoproxil fumarate in about 200 untreated adults with chronic hepatitis B, split into HBeAg-positive and HBeAg-negative cohorts. The primary endpoint in each cohort is suppression of HBV DNA below the lower limit of quantification, 10 IU/mL, at 48 weeks. The first prespecified interim analysis, covering the HBeAg-negative cohort, did not meet the study's futility criteria, and the DSMB recommended expanding Part 2a enrollment from 74 to 100 participants. The study drugs were reported well-tolerated through that checkpoint, with no viral breakthrough observed. NCT06963710+1A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)NCT06963710Aligos Therapeutics Provides Phase 2 B-SUPREME Study Progress UpdatesJan 21, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What's still ahead
A second protocol-defined interim analysis, covering the HBeAg-positive cohort, is planned once roughly 55 of those participants complete 24 weeks of treatment, a milestone the company said was reached in January 2026. That analysis is expected in the second half of 2026, and Aligos has guided topline data for both cohorts to 2027. Chairman, President and CEO Lawrence Blatt said the company expects the interim analyses to "contain directional insights on how the study is tracking" while the company remains blinded to subject-level data to preserve study integrity. AligosAligos Therapeutics Provides Phase 2 B-SUPREME Study Progress UpdatesJan 21, 2026
Enrollment and stability
Total study enrollment stands at its original target of 200 participants, unchanged, which the trial's own operational baseline model flags as a routine, non-signal enrollment level rather than a growth or cut. The registry shows one status change, from Not Yet Recruiting to Recruiting in July 2025, and no primary-completion-date revisions since the study's first posting in May 2025. The trial's primary completion date remains listed as March 1, 2027. NCT06963710A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)NCT06963710
The competitive frame
Pevifoscorvir sodium's molecular target has not been established in available registry data, so first-in-class status reads as unconfirmed rather than established or denied. Within chronic hepatitis B, 38 trials across the field have used small-molecule modalities, and the broader indication includes Phase 3 programs from Ausper Biopharma, Fujian Shengdi Pharmaceutical, and Fujian Akeylink Biotechnology, none of which share pevifoscorvir sodium's specific mechanism class. No direct comparator trial testing the same target has been identified for this asset. NCT06963710A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)NCT06963710
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.