GSK’s Bepirovirsen Delivers Functional Cure in 1,800+ Patients Across Two Phase III Trials
GSK’s investigational antisense oligonucleotide bepirovirsen achieved statistically significant functional cure rates in over 1,800 chronic hepatitis B patients across two Phase III B-Well 1 and 2 trials, meeting primary endpoints and positioning a potential six-month finite therapy. The company plans global regulatory submissions for bepirovirsen in Q1 2026.
1. Bepirovirsen Achieves Primary Endpoints in Phase III Hepatitis B Trials
GSK’s investigational antisense oligonucleotide, bepirovirsen, met its primary endpoint in two large Phase III studies (B-Well 1 and B-Well 2) involving over 1,800 chronic hepatitis B patients. Both trials demonstrated statistically significant functional cure rates—defined as sustained loss of hepatitis B surface antigen—at Week 24 following a six-month treatment course. In B-Well 1, 12.3% of patients achieved functional cure versus 1.8% on standard of care, while B-Well 2 saw rates of 11.7% versus 2.1%. These results support GSK’s plan to file regulatory submissions in Q1 2026 for the first finite, six-month therapeutic option in this indication.
2. Strategic Partnership with Noetik to Accelerate Cancer R&D
In a landmark deal, GSK has licensed Noetik’s AI foundation models under an anchor partnership designed to revolutionize cancer therapeutic research and development. The collaboration grants GSK access to Noetik’s deep‐learning platform, capable of analyzing multi‐omic datasets and predicting target-drug interactions. GSK will deploy these models across its oncology pipeline, starting with preclinical lead identification in solid tumors. The agreement includes tiered milestone payments of up to $150 million and royalties on future product sales, reinforcing GSK’s commitment to harnessing artificial intelligence for faster, more cost-effective drug discovery.