SOUTH SAN FRANCISCO, Calif., July 13, 2026 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has completed enrollment of both the HBeAg+ (Part 1a) and HBeAg- (Part 2a) participants in the Phase 2 B-SUPREME study of pevifoscorvir sodium, under development for the treatment of chronic hepatitis B virus (HBV) infection. Topline safety and efficacy data are expected to be available in late third quarter of 2027.
Part 1a completed enrollment of 131 HBeAg+ participants. This represents an over enrollment prior to the planned second interim analysis; therefore, the second interim analysis for sample size re-estimation will not be performed. Part 2a also completed enrollment of 114 HBeAg- participants.
"We are pleased to announce the completion of enrollment in our global Phase 2 B-SUPREME study of pevifoscorvir sodium," said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "Achieving full enrollment across study sites worldwide represents an important milestone for our organization and reflects the dedication of patients, investigators, healthcare professionals, and the Aligos team. This accomplishment advances our mission to develop transformative therapies for chronic hepatitis B virus infection and to reduce the burden of end-stage liver disease and hepatocellular carcinoma. We are deeply grateful to all study participants and their families for their commitment to this research. We look forward to reporting topline results in the late third quarter of next year and to continuing the advancement of pevifoscorvir sodium toward potential registration."
About B-SUPREME
The Phase 2 B-SUPREME study (NCT06963710) is a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of pevifoscorvir sodium monotherapy compared with tenofovir disoproxil fumarate in approximately 250 untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection for 48 weeks. The primary endpoint in the HBeAg+ part is HBV DNA
About pevifoscorvir sodium
Pevifoscorvir sodium (formerly known as ALG-000184) was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. Pevifoscorvir sodium is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B virus (HBV) infection. Phase 1 studies have demonstrated after single and multiple daily doses that pevifoscorvir sodium was well-tolerated by study participants, with no safety signals observed, and demonstrated linear PK and excellent antiviral activity. In longer term Phase 1 studies, pevifoscorvir sodium 300mg QD x =96 weeks monotherapy has demonstrated sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Pevifoscorvir sodium has a regulatory path, as acknowledged by the FDA, EMA, and NMPA (China), for subsequent studies utilizing the chronic suppressive pathway.
About Chronic HBV Infection
Chronic hepatitis B virus (HBV) infection is a life-threatening viral infection that primarily affects the liver with 240 million patients worldwide and approximately 1 million individuals become newly infected every year despite the availability of a prophylactic vaccine. Complications include cirrhosis, end-stage liver disease, and hepatocellular carcinoma, which collectively resulted in approximately 1.1 million deaths in 2024, according to the World Health Organization. Chronic HBV infection is the primary cause of liver cancer worldwide, and the mortality associated with HBV-related liver cancer continues to increase.
About Aligos
Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), obesity, and coronaviruses.
For more information, please visit www.aligos.com or follow us on LinkedIn or X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation, statements regarding Aligos' research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials, such as the availability of topline data from the B-SUPREME Study in late Q3 2027, and the advancement of pevifoscorvir sodium toward potential registration. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos' clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos' capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2026 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Investor Contact
Aligos Therapeutics, Inc.
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
Media Contact
Inizio Evoke
Jake Robison
Vice President
Jake.Robison@inizioevoke.com
