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Positive phase 3 data for GSK's bepirovirsen
GSK plc announced positive results from its B-Well 1 and B-Well 2 phase III trials for bepirovirsen, a potential first-in-class treatment for chronic hepatitis B, which affects over 250 million people worldwide and is a leading cause of liver cancer. The trials, involving over 1,800 patients across 29 countries, met their primary endpoint, demonstrating a statistically significant and clinically meaningful functional cure rate for bepirovirsen when used in combination with standard of care, a significant improvement over the current 1% functional cure rate with standard of care alone. Global regulatory filings are planned from the first quarter of 2026. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 7 January 2026, London UK\n \nGSK announces positive results from B-Well 1 and B-Well 2 phase III trials for bepirovirsen, a potential first-in-class treatment for chronic hepatitis B\n \n· Primary endpoint met in both trials\n· Bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate\n· Chronic hepatitis B (CHB) accounts for ~56% of liver cancer cases[1] and affects more than 250 million people worldwide[2]\n· Global regulatory filings planned from Q1 2026\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced positive results from its two pivotal phase III trials, B-Well 1 [NCT05630807] and B-Well 2 [NCT 05630820], evaluating bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB) in over 1,800 patients from 29 countries.\n \nCHB is a major health challenge affecting over 250 million people worldwide and is the leading cause of liver cancer. The current standard of care - nucleos(t)ide analogues - often requires lifelong therapy and the functional cure rates remain low, typically only 1%.[3] Functional cure for CHB is when the virus can no longer be detected in the blood, as measured by the sustained loss of hepatitis B surface antigen - a viral protein that signals ongoing infection - and undetectable hepatitis B virus DNA for at least 24 weeks after a finite course of treatment. This allows the immune system to control the infection without further medication. Functional cure is associated with significant reduction in the risk of long-term liver complications, including liver cancer, as well as all -cause mortality.[4], [5]\n \nThe B-Well trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone. Results were statistically significant across all ranked endpoints, including in patients with baseline surface antigen (HBsAg) <=1000 IU/ml where an even greater effect was demonstrated. The trials demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies. \n \nTony Wood...