Data Readout

Aligos targets 2026 for first interim data on HBV pill ALG-000184

The oral capsid assembly modulator had all 11 HBeAg-negative Phase 1 subjects reach sustained viral suppression through 96 weeks; a 200-subject randomized trial against tenofovir is next.

By AppliedXLJuly 13, 2026Trial NCT04746183

Executive Summary

Aligos Therapeutics is moving its capsid assembly modulator for chronic hepatitis B into a randomized, active-controlled trial after an uncontrolled Phase 1 study showed durable viral suppression, and 2026 marks the first checkpoint where that signal gets tested against the standard of care.
Early data from monotherapy dosing showed nearly complete viral suppression sustained out to 96 weeks in both viral-antigen subgroups, a result the company has framed as best-in-class, though the study carried no comparator arm.
An interim look in 2026 will be the first randomized comparison against tenofovir, the entrenched oral therapy for chronic HBV, ahead of a fuller topline dataset expected a year later that will determine whether the mechanism can compete with, rather than just precede, standard care.
Chronic HBV drug development includes few late-stage rivals sharing this specific capsid-assembly approach, so the trial's outcome will carry disproportionate weight for how the mechanism class is read going forward.

The stake

Aligos Therapeutics, Inc. is developing ALG-000184, an oral small-molecule capsid assembly modulator, or CAM-E, for chronic hepatitis B virus infection, a disease with no approved cure and where tenofovir disoproxil fumarate remains the entrenched oral standard for viral suppression. The company has described ALG-000184 as a potential backbone therapy for a functional cure regimen. Whether it can match or beat tenofovir head-to-head, rather than simply outperform no treatment, is the question the current trial is built to answer. Aligos

How it was done: Phase 1

Interim data through up to 96 weeks of daily 300 mg oral dosing were presented at the European Association for the Study of the Liver Congress in 2025. The design was a single-arm, open-label extension without an active comparator. In HBeAg-positive subjects with a baseline HBV DNA level of 8.0 log10 IU/mL, 6 of 10 subjects reached HBV DNA below the lower limit of quantification (10 IU/mL) at week 48; with extended treatment, 9 of 9 subjects still on study reached that threshold by week 96, and 5 of 9 reached the more stringent target-not-detected level. In HBeAg-negative subjects, all 11 reached sustained suppression by week 24 and held that response through 96 weeks. Aligos said the drug was well tolerated over that period. Aligos

The next test

The Phase 2 B-SUPREME study, registered as NCT04746183 in the underlying catalyst record, is designed as a randomized, double-blind, active-controlled trial enrolling approximately 200 untreated HBeAg-positive and HBeAg-negative adults with chronic HBV infection, comparing ALG-000184 monotherapy against tenofovir disoproxil fumarate over 48 weeks. The primary endpoint in HBeAg-positive subjects is HBV DNA below 10 IU/mL, whether target detected or not detected; in HBeAg-negative subjects, it is the more stringent target-not-detected threshold. The study also tracks pharmacokinetics and biomarkers including HBV antigen reduction. Aligos said site activation and subject screening were underway as of August 2025, with dosing expected to begin within weeks. Aligos

Timing

Aligos has guided to interim data from B-SUPREME in 2026 and topline data in 2027. That sequencing means the 2026 disclosure is a partial look, likely covering safety and early virologic response rather than the full 48-week comparator analysis needed to judge the drug against tenofovir on its own terms. The company has also said it expects additional post-treatment follow-up data from the Phase 1 study at scientific conferences. Aligos

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