GSK Presents Promising New Data for Bepirovirsen, an Investigational Treatment for Chronic Hepatitis B

GSK plc today announced promising interim results from the B-Clear phase IIb trial showing that bepirovirsen, an investigational antisense oligonucleotide treatment for hepatitis B, reduced levels of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA after 24 weeks’ treatment in people with chronic hepatitis B (CHB).

These interim analysis data were presented today in an oral late-breaker session at the European Association for the Study of the Liver’s International Liver Congress 2022 in London, UK. The final results from the study will be submitted for presentation at a scientific congress later this year, and for publication in a peer-reviewed journal.

Chris Corsico, SVP, Development, GSK, said: “Chronic hepatitis B affects nearly 300 million people with approximately 900,000 patients dying each year from its associated complications.^[1],[2] These encouraging data support further investigation of bepirovirsen, both as monotherapy and in combination, as a potentially transformative new treatment option for patients with chronic hepatitis B.”

Current treatment options have limited success in leading to functional cure, where the virus is not eliminated from the body but is at low levels that are undetectable in blood and can be controlled by the immune system without medication. The mainstay of therapy includes nucleoside/nucleotide analogues (NA) which are often taken for life because they suppress but rarely clear the virus.  Bepirovirsen’s unique mechanism of action works to reduce HBV replication, suppress HBsAg and stimulate the immune system. Bepirovirsen has the potential to lead to functional cure in patients with CHB.

Professor Man-Fung Yuen, Principal Investigator and Chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, The University of Hong Kong, said: “The data presented today are a promising step forward for the millions of people living with chronic hepatitis B worldwide. Specifically, the reduction in hepatitis B surface antigen and HBV DNA to below the lower limit of quantification has the potential to be clinically meaningful and lead to functional cure. This could help people living with CHB and healthcare providers manage the long-term consequences of CHB which include the social burden as well as the risk of developing life-threatening liver complications.”

GSK is also exploring combinations of bepirovirsen and other therapeutic modalities in the following trials. Combination treatments could increase functional cure rates in more patients, thereby further reducing the global disease burden of CHB. Trials include:

• Phase IIb trial of bepirovirsen in sequential combination with pegylated interferon (PegIFN) treatment
• Phase II trial of bepirovirsen in combination with GSK’s chronic hepatitis B targeted immunotherapy