Global pharma giant GSK has announced that its investigational drug bepirovirsen achieved positive results in chronic hepatitis B trials.

 

The two pivotal Phase III trials, B-Well 1 and B-Well 2, involving over 1,800 patients across 29 countries, tested bepirovirsen, an antisense oligonucleotide (ASO), for the treatment of chronic hepatitis B (CHB), a condition affecting more than 250 million people worldwide and the leading cause of liver cancer.

 

The studies met their primary endpoint, with bepirovirsen demonstrating a statistically significant and clinically meaningful functional cure rate. Patients receiving bepirovirsen plus standard therapy showed higher cure rates compared with standard therapy alone, with particularly strong results in those with lower baseline hepatitis B surface antigen (HBsAg ≤1000 IU/ml). Safety and tolerability were consistent with previous studies.

 

Functional cure – when the virus is undetectable in the blood and the immune system can control infection without ongoing medication – dramatically reduces the risk of long-term liver complications, including liver cancer, and all-cause mortality. Current therapies achieve this in only about 1% of patients and often require lifelong treatment.

 

Tony Wood, Chief Scientific Officer at GSK, said: “Bepirovirsen has the potential to transform treatment goals for people living with CHB by achieving significant functional cure rates – a first for the disease. CHB affects more than 250 million people and leads to approximately 56% of liver cancer cases worldwide. 

 

"Today’s result supports our plans to progress bepirovirsen as a treatment and also continue its development as a backbone in future sequential therapies. We’re pleased by this major advance in our expanding hepatology pipeline, aimed to transform outcomes in liver disease.”

 

The results mark a major milestone in GSK’s effort to advance CHB treatment, offering hope for the first widely available therapy capable of achieving meaningful functional cures in a disease that has long been considered largely incurable.