Aligos Therapeutics, Inc. (ALGS) announced encouraging first interim results from its Phase 2 B-SUPREME study of Pevifoscorvir sodium in adults with chronic hepatitis B virus (HBV) infection.
The independent Data Safety Monitoring Review Board (DSMB) recommended continuing the study and increasing enrolment in the HBeAg-negative cohort to strengthen statistical power, noting that futility criteria were not met.
Chronic HBV affects more than 250 million people worldwide and remains a leading cause of liver cancer. Current therapies often suppress but rarely eliminate the virus, leaving a significant unmet need.
The B-SUPREME trial is a randomized, double-blind, multicentre study comparing Pevifoscorvir sodium monotherapy with tenofovir disoproxil fumarate in approximately 200 untreated HBV patients. The primary endpoint measures reduction of HBV DNA to below detectable levels. Interim findings showed the drug was well tolerated, with no concerning safety signals or viral breakthrough observed. Enrollment in the HBeAg-negative cohort is expected to complete in the second half of 2026, with topline data anticipated in 2027.
"We are encouraged by the DSMB's recommendation to expand enrolment, which increases the probability of success at the primary endpoint," said Lawrence Blatt Chairman, President, and CEO of Aligos. "We are also thrilled that Pevifoscorvir sodium has been granted Fast Track Designation, underscoring its potential to address unmet needs in chronic HBV."
The designation was supported by long-term Phase 1 data showing sustained reductions in key viral markers and favorable tolerability.
Aligos continues to advance its pipeline in liver and viral diseases, including metabolic dysfunction-associated steatohepatitis (MASH), obesity, and coronaviruses.
ALGS has traded between $4.20 and $13.69 over the past year. The stock is currently trading at $7.50, down 14.19%.
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