Aligos Therapeutics Announces First Subject Dosed in the Phase 2 B-SUPREME Study of ALG-000184 in Subjects with Chronic HBV Infection

Core Insights - Aligos Therapeutics has initiated dosing in the Phase 2 B-SUPREME study for its investigational compound ALG-000184 targeting chronic hepatitis B virus (HBV) infection [1][2][3] - The study aims to evaluate the safety and efficacy of ALG-000184 compared to tenofovir disoproxil fumarate in approximately 200 untreated adult subjects over 48 weeks [2][3] - Chronic HBV infection affects 254 million patients globally, with approximately 1.08 million deaths attributed to complications in 2022 [4] Company Overview - Aligos Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for liver and viral diseases [5][6] - The company aims to improve patient outcomes through best-in-class therapies, leveraging its R&D expertise [5][6] Product Details - ALG-000184 is a small molecule capsid assembly modulator (CAM-E) showing promising antiviral activity and good tolerability in Phase 1 studies [3] - The Phase 1 studies demonstrated sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg [3] - The regulatory path for ALG-000184 has been acknowledged by the FDA, EMA, and NMPA for further studies [3] Clinical Study Information - The Phase 2 B-SUPREME study is a randomized, double-blind, active-controlled multicenter trial [2][3] - Primary endpoints include achieving HBV DNA levels below the lower limit of quantification (LLOQ) [2] - Interim data is expected in 2026, with topline data anticipated in 2027 [2][3] Industry Context - Chronic HBV infection is a significant global health issue, with increasing mortality rates associated with liver cancer [4] - The need for improved therapies is underscored by the limitations of current treatment options [2][4]