Aligos Therapeutics announced the dosing of the first subject in its Phase 2 B-SUPREME study of ALG-000184 for chronic hepatitis B virus (HBV) infection. The B-SUPREME study is a randomized, double-blind, active-controlled multicenter trial. It will evaluate the safety and efficacy of ALG-000184 monotherapy against tenofovir disoproxil fumarate in approximately 200 untreated HBeAg-positive and HBeAg-negative adult subjects over 48 weeks.
The primary endpoint for HBeAg-positive subjects is HBV DNA below the lower limit of quantification (10 IU/mL), while for HBeAg-negative subjects, it is HBV DNA below the lower limit of quantification (target not detected). Regulatory approvals for the study have been secured in several countries, including the US, China, Canada, Taiwan, UK, New Zealand, and Moldova.
Interim data from this pivotal study is projected in 2026, with topline data anticipated in 2027. This milestone is crucial for validating ALG-000184's potential as a first-in-class or best-in-class therapy for chronic HBV infection, building on impressive antiviral activity observed in prior clinical trials.
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