Aligos Therapeutics Completes HBeAg Dual Cohort Enrollment in Phase 2 B-SUPREME Trial for HBsAg-Suppressed Patients with Chronic Hepatitis B

Aligos Therapeutics Completes HBeAg Dual Cohort Enrollment in Phase 2 B-SUPREME Trial for HBsAg-Suppressed Patients with Chronic Hepatitis B

Aligos Therapeutics, Inc. (ALGS), a clinical-stage biotechnology company, announced Monday that it has successfully enrolled 131 hepatitis B virus (HBV) patients in the HBeAg-positive cohort (Part 1a) and 114 patients in the HBeAg-negative cohort (Part 2a) of its Phase 2 B-SUPREME trial. The clinical study, which initially planned to temporarily halt enrollment following an interim analysis to reassess sample size, bypassed the pause due to unexpectedly strong participation in Part 1a. Aligos now anticipates releasing topline safety and efficacy data in late third quarter of 2027.

The multicenter trial evaluates the safety, efficacy, and pharmacokinetics of pevifoscorvir sodium monotherapy against tenofovir disoproxil fumarate in 250 treatment-naïve adults with chronic HBV infection. Primary efficacy endpoints focus on achieving HBV DNA suppression below the lower limit of quantification (10 IU/mL) in HBeAg-positive patients and undetectable HBV DNA in HBeAg-negative patients, with additional assessments of antigen reduction (HBsAg, HBeAg, HBcrAg) and secondary biomarkers tracking disease progression.

Pevifoscorvir sodium, an investigational oral small-molecule capsid assembly modulator developed from Emory University’s technology and optimized by Aligos, demonstrated favorable safety profiles in prior trials. The company’s Phase 1 studies reported no safety signals, consistent linear pharmacokinetics, and sustained reductions in HBV genetic and antigen markers when administered as monotherapy. Current trial design aligns with these prior findings while incorporating comparative efficacy data against the established standard of care.

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