GSK (LSE:GSK) said it has achieved positive topline results from its pivotal Phase III B-Well 1 and B-Well 2 studies of bepirovirsen, an investigational antisense oligonucleotide designed as a finite six-month therapy for chronic hepatitis B (CHB). The disease affects more than 250 million people worldwide and is a leading cause of liver cancer. The successful readout marks a significant step toward offering a treatment approach that could move beyond lifelong viral suppression.
The two trials enrolled more than 1,800 patients across 29 countries and met their primary endpoints, demonstrating statistically significant and clinically meaningful functional cure rates when bepirovirsen was added to standard nucleos(t)ide analogue therapy, compared with standard care alone. GSK said the treatment effect was particularly pronounced in patients with lower baseline hepatitis B surface antigen levels, while the overall safety profile was considered acceptable.
Based on these results, GSK plans to begin regulatory submissions globally from early 2026. If approved, bepirovirsen could become the first finite therapy for chronic hepatitis B and serve as a foundation for future sequential treatment strategies. Management believes this could materially strengthen GSK’s hepatology franchise and represent a major shift in how the disease is managed over the long term, with potential benefits for both patients and healthcare systems.
From an investment perspective, GSK’s outlook is supported by its strong financial performance and relatively attractive valuation metrics. Ongoing strategic actions, including share buybacks and sustained investment in research and development, underpin confidence in future growth. These positives are balanced by pressures in certain business segments and ongoing cash flow considerations, suggesting a more measured outlook despite the clinical success.
More about GlaxoSmithKline
GSK is a global biopharmaceutical company focused on developing innovative medicines and vaccines, guided by its aim to get ahead of disease. The group has a growing hepatology pipeline and targets areas of significant unmet medical need, including infectious diseases with large global impact such as chronic hepatitis B.
Leave a Reply