Aligos Reports Enrollment Milestones In Phase 2 B-SUPREME Study Of Pevifoscorvir Sodium In Chronic Hepatitis B Infection

Aligos Therapeutics provided a progress update on its ongoing Phase 2 B-SUPREME clinical trial evaluating pevifoscorvir sodium (ALG-000184) in patients with chronic hepatitis B virus (HBV) infection. The first protocol-defined interim analysis will include about 60% of enrolled HBeAg-negative patients who have completed 12 weeks of treatment. This enrollment milestone was achieved in the fourth quarter of 2025, with full enrollment of the HBeAg-negative cohort completed in January 2026. The company expects to conduct this interim analysis in the first half of 2026.

A second interim analysis is planned for the HBeAg-positive cohort once approximately half of these patients complete 24 weeks of therapy. This enrollment milestone was reached in January 2026, and the corresponding interim analysis is anticipated in the second half of 2026. These analyses are designed to assess protocol-defined endpoints while allowing for potential sample-size adjustments.

“2026 is an important year for Aligos as we continue to make progress with the Phase 2 B-SUPREME study with 144 subjects currently enrolled across the world,” stated Lawrence Blatt, PhD, M.B.A., Chairman, President, and CEO. “We look forward to our interim analyses, which will contain directional insights on how the study is tracking. The study remains on track to complete enrollment, with topline data expected in 2027. We believe pevifoscorvir sodium is poised for success in this study and look forward to sharing more details later this year.”

To maintain trial integrity and adhere to FDA regulatory standards, Aligos will remain blinded to patient-level data. Oversight will be provided by an independent Data Safety Monitoring Board, which will review safety and efficacy assessments and advise the company on protocol-specified considerations, including any re-estimation of sample size.

In a separate update, Aligos announced that Dr. Hardean Achneck has stepped down from his role as Executive Vice President and Chief Medical Officer. The company expressed appreciation for his contributions and has initiated a formal search to appoint a successor. The Phase 2 B-SUPREME study continues to evaluate the safety, antiviral activity, pharmacokinetics, and additional biomarkers of ALG-000184 compared with standard-of-care tenofovir in approximately 200 untreated HBV patients.