drugset / Press release

GSK presents scientific advances to improve patient outcomes at the American Association for the Study of Liver Diseases’ The Liver Meeting® 2023

2023-10-11 · GlaxoSmithKline · original gsk.com ↗

New data from the B-Together phase IIb trial assessing the potential of a sequential treatment regimen of bepirovirsen followed by pegylated interferon alpha reflect contribution to the development of a functional cure for people living with chronic hepatitis B (CHB) GSK plc (LSE/NYSE: GSK) will present 14 abstracts at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® 2023, taking place in Boston, MA from 10-14 November. Presentations feature data from two novel investigational specialty medicines, bepirovirsen, an antisense oligonucleotide (ASO) for chronic hepatitis B (CHB), and linerixibat, an ileal bile acid transporter (IBAT) inhibitor for cholestatic pruritus in primary biliary cholangitis (PBC). Key data include the first oral presentation of full results from the B-Together phase IIb trial investigating bepirovirsen followed by pegylated interferon alfa (Peg-IFN) as treatment for people with CHB on nucleos(t)ide analogue therapy. Chris Corsico, SVP, Development, GSK said: “We’re looking forward to highlighting research in a variety of serious liver conditions, stemming from our expertise in infectious disease, immunology and human genetics. Our presentations include new data for bepirovirsen which not only further our understanding of its durability of response and role as a future backbone of chronic hepatitis B treatment, but also improve our understanding of the heterogeneous nature of hepatitis B infections. These data across chronic liver diseases demonstrate our enduring commitment to ultimately improve patient care.” Advancing the science for bepirovirsen, being investigated as the backbone of treatment regimens for people with CHB The B-Together phase IIb trial assessed the potential for bepirovirsen followed by Peg-IFN as a sequential regimen to treat CHB infection, reduce hepatitis B surface antigen (HBsAg), and lower virus (HBV) DNA in the blood. The primary endpoint was the proportion of patients with HBsAg and HBV DNA below the lower limit of quantification (LLOQ) for 24 weeks after planned end of sequential treatment, in the absence of newly initiated antiviral therapy (rescue therapy). All patients that met the primary endpoint had a baseline surface antigen ≤3000 IU/mL, reinforcing the previously announced results from the B-Clear phase IIb trial which showed that treatment with bepirovirsen resulted in sustained clearance of HBsAg and HBV DNA both in patients on concurrent nucleoside/nucleotide analogues (NA) and patients not-on-NA therapy. The findings from the B-Together trial contribute to the goal of a functional cure for people living with CHB, as we apply important insights to additional treatment approaches to match the right therapy to appropriate patients. Raising awareness of the impact of cholestatic pruritus on quality of life for people living with PBC Data highlight the impact of pruritus, a debilitating itch related to the release of bile acids through the body, in people living with PBC as well as the need to urgently identify, and better manage, itch. Further data describe how, in patients with PBC and itch, reductions in serum biomarkers are associated with a clinical response to linerixibat. GSK’s presentations at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® 2023 include:

The release as fetched from its publisher. gsk.com ↗