The B-Clear study investigated the efficacy and safety of 12- or 24-weeks treatment with bepirovirsen in individuals with chronic hepatitis B.
GSK announced interim results from the B-Clear phase 2b trial, showing that bepirovirsen, an investigational antisense oligonucleotide treatment for hepatitis B virus(HBV), reduced the levels of hepatitis B surface antigen (HBsAg) and HBV DNA after 24 weeks of treatment in individuals with chronic hepatitis B (CHB).
“[CHB] affects nearly 300 million people with approximately 900,000 patients dying each year from its associated complications. 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,” Chris Corsico, SVP of Development at GSK, said in a statement.
The interim data were presented in an oral late-braker session at the European Association for the Study of the Liver’s International Liver Congress 2022 in London, United Kingdom. The final results will be submitted to a peer-reviewed journal and presented at a scientific congress later this year.
The B-Clear study investigated the efficacy and safety of 12- or 24-weeks treatment with bepirovirsen in individuals with CHB on stable nucleoside/nucleotide analogues (NA) treatment or not on NA treatment with bepirovirsen at the start of the study.
In both cohorts, investigators observed virologic responses at the end of the treatment. For those receiving NA treatment, 24 weeks of treatment of 300 mg bepirovirsen resulted in HBsAg less than Lower Limit of Quantification (LLOQ) and HBV DNA less than LLOQ in 28% of individuals.
For those not on NA, the same treatment resulted in HBsAg less than LLOQ and HBV DNA less than LLOQ in 29% of individuals. Current treatment options have limited success in leading to functional cure, where the virus is not eliminated from the body but is at levels low enough to be undetectable in blood and can be controlled by the immune system without medication.
The therapy includes nucleoside/nucleotide analogues, which are often taken for life because they suppress, but rarely clear the virus.
Bepirovirsen works to reduce HBV replication, suppress HBsAg and stimulate the immune system. It has the potential to lead to a functional cure in individuals with CHB.
“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,” Man-Fung Yuen, chief of Division of Gastroenterology and Hepatology at Queen Mary Hospital at The University of Hong Kong, said in the statement.
GSK is also exploring the combination of the drug and other therapeutic modalities in the following trials. The combination treatments could increase functional cure rates in more individuals and further reduce the global disease burden of CHB.
The trials include a phase 2 trial evaluating bepirovirsen in sequential combination with pegylated interferon treatment and a phase 2 trial evaluating bepirovirsen in combination with the company’s CHB targeted immunotherapy.
GSK presents promising new data for bepirovirsen, an investigational treatment for chronic hepatitis B. GSK. News release. June 25, 2022. Accessed June 29, 2022. https://www.gsk.com/en-gb/media/press-releases/gsk-presents-promising-new-data-for-bepirovirsen-an-investigational-treatment-for-chronic-hepatitis-b/