SOUTH SAN FRANCISCO, Calif., July 13, 2026
Aligos Therapeutics announced the completion of patient enrollment in both parts of its global Phase 2 B-SUPREME clinical trial evaluating pevifoscorvir sodium for the treatment of chronic hepatitis B virus (HBV) infection. The study has successfully enrolled both HBeAg-positive and HBeAg-negative patient populations, marking a significant development milestone for the investigational oral antiviral therapy. With enrollment complete, the company expects to report topline safety and efficacy data in the late third quarter of 2027 as it continues advancing pevifoscorvir sodium toward potential regulatory registration.
Phase 2 Trial Completes Enrollment Across Both Patient Groups
The B-SUPREME study enrolled 131 HBeAg-positive participants in Part 1a, exceeding the originally planned enrollment target and eliminating the need for the scheduled second interim sample size re-estimation analysis. Part 2a also completed enrollment with 114 HBeAg-negative participants. The randomized, double-blind, active-controlled multicenter trial is evaluating approximately 250 treatment-naïve adults with chronic HBV infection over a 48-week treatment period. Participants are receiving either pevifoscorvir sodium monotherapy or the standard antiviral therapy tenofovir disoproxil fumarate, with primary endpoints measuring suppression of HBV DNA to below the lower limit of quantification in both patient populations.
Study Evaluates Safety and Antiviral Efficacy
Beyond the primary virologic endpoints, the Phase 2 study is designed to assess the safety profile, pharmacokinetics, and multiple secondary biomarkers associated with chronic HBV infection. Investigators will evaluate reductions in HBV DNA, viral antigens, and additional markers of viral activity to better understand the therapeutic potential of pevifoscorvir sodium. The investigational therapy is a next-generation capsid assembly modulator (CAM-E) designed to interfere with viral replication through a novel mechanism. Previous Phase 1 studies demonstrated favorable tolerability, predictable pharmacokinetics, and sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg during long-term treatment of up to 96 weeks.
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Pevifoscorvir Sodium Advances Toward Potential Registration
Pevifoscorvir sodium is being developed as a potential best-in-class oral therapy for chronic hepatitis B, a disease affecting approximately 240 million people worldwide and remaining a leading cause of cirrhosis, liver failure, and hepatocellular carcinoma. The investigational candidate has received regulatory alignment from the U.S. FDA, European Medicines Agency (EMA), and China’s National Medical Products Administration (NMPA) regarding its development pathway through the chronic suppressive treatment approach. With global enrollment now complete, Aligos is advancing one of its lead antiviral programs as part of its broader pipeline focused on liver diseases, metabolic disorders, obesity, and coronavirus infections, while working toward therapies that may reduce the long-term burden of chronic HBV and its associated complications.
Source:Aligos Therapeutics press release
