Bepirovirsen granted SENKU designation in Japan for chronic hepatitis B: GSK

The designation is based on results from the phase IIb B-Clear and B-Sure trials which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB. A confirmatory phase III programme, B-Well, is ongoing. This is the second regulatory designation in 2024 for bepirovirsen, following the US Food and Drug Administration (FDA) Fast Track designation for bepirovirsen granted earlier this year. 

CHB affects 257 million people worldwide, and nearly 1 million people in Japan. Current treatment options provide a functional cure rate of less than 2-8% for pegylated interferon (PegIFN) and less than 1% for oral treatments (nucleoside/nucleotide analogues [NAs]). Functional cure occurs when the hepatitis B virus DNA and viral protein, hepatitis B surface antigen (HBsAg), are at levels low enough to be undetectable in the blood and can be controlled by the immune system without medication. Current therapies only suppress the virus and do not directly lower HBsAg, which is essential for functional cure.

According to GSK, Bepirovirsen is the only single agent in phase III development that has shown the potential to achieve clinically meaningful functional cure response when combined with oral NAs. Bepirovirsen is also being investigated as a potential backbone therapy in future sequential regimens to pursue functional cure in a broader population of patients with CHB.