SOUTH SAN FRANCISCO, Calif., April 14, 2026

Aligos Therapeutics, Inc. has announced encouraging progress in its Phase 2 B-SUPREME clinical trial evaluating pevifoscorvir sodium, alongside receiving U.S. Food and Drug Administration (FDA) Fast Track Designation for the treatment of chronic hepatitis B virus (HBV) infection. The dual milestone highlights the company’s advancing position in addressing one of the most persistent global viral diseases, reinforcing its mission to deliver next-generation therapies for liver and infectious diseases..

Interim Analysis Supports Continued Clinical Progress

The first interim analysis of the Phase 2 B-SUPREME study demonstrated positive safety and feasibility outcomes, with the independent Data Safety Monitoring Board (DSMB) recommending continuation of the study and an increase in sample size to optimize statistical power. Importantly, the pre-specified futility criteria were not met, indicating that the trial remains on track to achieve its primary endpoints.

The analysis included data from approximately 60% of participants in the HBeAg-negative cohort, with a total of 174 participants evaluated for safety. Results confirmed that pevifoscorvir sodium was well tolerated, with no clinically significant abnormalities in laboratory parameters, vital signs, or cardiac assessments. Additionally, no viral breakthrough events related to the therapy have been observed, further strengthening confidence in its antiviral potential.

These findings are critical in maintaining momentum for the program, as the study progresses toward full enrollment, expected to be completed in the second half of 2026. Topline data remains anticipated in 2027, positioning the therapy for potential late-stage development and regulatory engagement.

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Fast Track Designation Accelerates Regulatory Pathway

In a significant regulatory advancement, the FDA granted Fast Track Designation to pevifoscorvir sodium, recognizing its potential to address a serious condition with unmet medical need. This designation enables enhanced communication with regulators, eligibility for rolling review, and potential accelerated approval pathways, all of which can significantly shorten development timelines.

The Fast Track status is supported by previous Phase 1 data demonstrating strong antiviral activity and favorable safety profiles, including sustained reductions in key viral markers such as HBV DNA, RNA, and antigens. As a capsid assembly modulator (CAM-E), pevifoscorvir sodium targets a critical step in the HBV replication cycle, offering a novel mechanism of action that could complement or outperform existing therapies.

This regulatory milestone underscores the growing confidence in pevifoscorvir sodium as a potential best-in-class therapy, capable of transforming treatment paradigms for chronic HBV infection.

Addressing a Global Health Burden with Innovative Science

Chronic HBV infection remains a major global health challenge, affecting an estimated 254 million people worldwide and contributing to severe complications such as cirrhosis, liver failure, and hepatocellular carcinoma. Despite available vaccines, new infections and disease progression continue to drive significant morbidity and mortality, highlighting the urgent need for improved therapeutic options.

Aligos Therapeutics is leveraging its deep expertise in virology and liver disease biology to develop purpose-built antiviral therapies that target multiple stages of the viral lifecycle. Pevifoscorvir sodium’s ability to deliver sustained viral suppression and its favorable tolerability profile position it as a promising candidate in the evolving HBV treatment landscape.

The ongoing B-SUPREME study is designed as a randomized, double-blind, active-controlled trial, comparing pevifoscorvir sodium with standard-of-care therapy, further strengthening its clinical relevance. In addition to primary efficacy endpoints, the study is evaluating biomarkers and virological responses that could inform long-term treatment strategies.

With strong interim data, regulatory support, and a clear clinical roadmap, Aligos Therapeutics is advancing a high-potential therapy that could significantly improve outcomes for patients living with chronic hepatitis B. As the program progresses, its success could mark a pivotal step toward more effective and durable antiviral treatments, addressing a critical unmet need in global healthcare.

Source: Aligos Therapeutics press release