28th May 2026 10:57
(Alliance News) - GSK PLC on Thursday reported "positive" phase 3 trial data for its hepatitis B treatment, Bepirovirsen, which it said could "redefine" treatment for the disease.
The London-based pharmaceuticals firm said bepirovirsen achieved a "statistically significant and clinically meaningful" 19% functional cure response rate in the overall study population, meeting primary endpoints.
In a key secondary endpoint, a functional cure rate of 26% was achieved in participants with lower viral activity compared to 0% with standard of care only.
In addition, 49% of bepirovirsen recipients achieved a surface antigen level of less than, or equal to, 100 international units per milliliter one year after end of treatment in exploratory analysis. A loss in surface antigen is associated with a significant reduction in risk of liver cancer, GSK explained.
GSK said the drug achieved "unprecedented" functional cure rates with the potential to "redefine" treatment for chronic hepatitis B.
Tony Wood, chief scientific officer, GSK, said: "For the first time, bepirovirsen offers the possibility of significantly better functional cure rates than the current standard of care, and the potential to reduce the risk of long-term liver complications, including cancer. This is a major step forward in our growing pipeline to treat liver disease to help transform outcomes for patients."
The results came from two phase 3 trials, B-Well 1 and B-Well 2. The trials showed an acceptable safety and tolerability profile consistent with other studies of bepirovirsen, GSK said.
Bepirovirsen is currently under priority review by the US Food & Drug Administration with both Breakthrough and Fast Track Designation. It is also under review by regulatory authorities in Europe, Japan and China.
GSK anticipates the first regulatory decisions in the third quarter of 2026, and said launch preparations are underway.
Earlier this month, GSK entered a strategic collaboration with Sino Biopharmaceutical Ltd that aims to accelerate patient access to bepirovirsen at launch in China.
Shares in GSK were down 0.6% at 1,927.50 in London on Thursday, with the wider FTSE 100 trading 0.8% lower.
By Jeremy Cutler, Alliance News reporter
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