Aligos Therapeutics Provides Phase 2 B-SUPREME Study Progress Updates

Core Insights - Aligos Therapeutics is progressing with the Phase 2 B-SUPREME study of pevifoscorvir sodium for chronic hepatitis B virus (HBV) infection, with interim analyses scheduled for 2026 [1][2] Study Progress - The Phase 2 B-SUPREME study currently has 144 subjects enrolled globally, with expectations for interim analyses to provide insights on study tracking [2] - The first interim analysis will include approximately 60% (36) of HBeAg- participants who have completed 12 weeks of treatment, expected in the first half of 2026 [3] - A second interim analysis is planned for when about 50% (55) of HBeAg+ participants complete 24 weeks of treatment, anticipated in the second half of 2026 [4] Regulatory Compliance - To maintain study integrity and comply with FDA regulations, the company will remain blinded to subject-level data and will receive insights from the Data Safety Monitoring Board [5] Leadership Update - Hardean Achneck, MD has resigned as Executive Vice President and Chief Medical Officer, and a search for his successor is underway [6] Study Details - The Phase 2 B-SUPREME study is a randomized, double-blind, active-controlled multicenter trial evaluating the safety and efficacy of ALG-000184 monotherapy compared to tenofovir disoproxil fumarate in approximately 200 untreated adult subjects with chronic HBV infection for 48 weeks [7] - The primary endpoint for HBeAg- participants is HBV DNA <LLOQ (10 IU/mL), while for HBeAg+ participants, it is also HBV DNA <LLOQ (10 IU/mL) [7] Product Information - Pevifoscorvir sodium, previously known as ALG-000184, is a potential first-in-class oral small molecule capsid assembly modulator being developed for chronic HBV infection [8] - Phase 1 studies have shown that pevifoscorvir sodium is well-tolerated, with no safety signals and demonstrated linear pharmacokinetics and excellent antiviral activity [8]