GSK reported results from two Phase III clinical trials, B-Well 1 and B-Well 2, evaluating bepirovirsen in people with chronic hepatitis B virus infection. The primary endpoint was met in both studies. The trials enrolled more than 1,800 participants across 29 countries. Bepirovirsen is an investigational antisense oligonucleotide administered for a defined treatment period in combination with standard therapy. The primary endpoint was defined as loss of hepatitis B surface antigen (HBsAg) and sustained undetectable HBV DNA after completion of treatment.
The company said it plans to submit regulatory applications in selected markets from the first quarter of 2026. Detailed data are expected to be presented at an upcoming scientific congress. Chronic HBV infection remains a major cause of liver disease worldwide.