GSK to present new data from the B-Clear phase IIb trial for bepirovirsen in chronic hepatitis B at the International Liver Congress 2022
For investors and media only
Further phase II data to be shared on linerixibat for cholestatic pruritus in primary biliary cholangitis
Issued: London UK
GSK plc will present 12 abstracts at the European Association for the Study of the Liver’s International Liver Congress 2022, taking place on June 22-26 in London. GSK’s presence will focus on two novel investigational specialty medicines, bepirovirsen, an antisense oligonucleotide for chronic hepatitis B (CHB), and linerixibat, an ileal bile acid transporter (IBAT) inhibitor for cholestatic pruritus in primary biliary cholangitis (PBC).
Chris Corsico, SVP, Development, GSK said: “New data being shared at this year’s International Liver Congress support our ambition to deliver novel medicines for patients with significant unmet medical need, such as those who suffer from chronic hepatitis B and cholestatic pruritus in primary biliary cholangitis. We look forward to engaging with the global hepatology community to share the exciting progress we have made for these patients.”
Updates from the bepirovirsen clinical trial programme
New interim analysis data to be shared from the randomised B-Clear phase IIb trial evaluating the efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection on and off stable nucleos(t)ide analogue therapy. Data from this trial will be presented as part of the Late Breaker oral presentation session on June 25 (ILC oral # LB004A, LB004B).
Additional presentations from the bepirovirsen development programme include:
Preclinical evidence that bepirovirsen harbours intrinsic immunostimulatory activity via Toll-like receptor 8 (TLR8), correlating with clinical efficacy from the study (ILC abstract #3635/ SAT439)
Mechanistic pharmacokinetic and pharmacodynamic modelling of the simultaneous effects of bepirovirsen on hepatitis B surface antigen (HBsAg) and alanine transaminase (ALT) changes in CHB (ILC abstract #3592/ SAT441).
Data from these trials reflect GSK’s ambition to contribute to the development of a functional cure for people living with CHB and reduce the disease burden for patients.
Bepirovirsen
Abstract Name Presenter Presentation details
Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection: interim results from the randomised phase 2b B-Clear study
Man-Fung Yuen
Oral (LB004A, LB004B)Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection not on stable nucleos(t)ide analogue therapy: interim results from the randomised phase 2b B-Clear study
Seng-Gee Lim
Poster (3595/ SAT452)
Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection on stable nucleos(t)ide analogue therapy: interim results from the randomised phase 2b B-Clear study
Man-Fung Yuen
Poster (3629/ SAT453)
Evaluation Of Quantitative HBsAg Levels In Chronic Hepatitis B – A Targeted Literature Review
Vera Gielen
Poster (1850/ SAT405)
Characterisation of baseline complement values in patients with chronic hepatitis B virus infection in the phase IIb B-Clear study
Jennifer Cremer
Poster (1994/ THU390)
Characteristics and renal function in patients with chronic hepatitis B virus infection: baseline data from the phase 2b B-Clear study
Seng-Gee Lim
Poster (1879/ THU389)
Distribution of patients by guideline-defined disease phase and/or grey zones in B-Clear, an international multi-centre clinical trial
Seng-Gee Lim
Poster (2127/ THU393)
Bepirovirsen, antisense oligonucleotide (ASO) against hepatitis B virus (HBV), harbors intrinsic immunostimulatory activity via Toll-like receptor 8 (TLR8) preclinically, correlating with clinical efficacy from the Phase 2a study
Shihyun You
Poster (3635/ SAT439)
Mechanistic Pharmacokinetics/Pharmacodynamics modelling of the simultaneous effects of bepirovirsen on Hepatitis B surface antigen (HBsAg) and alanine transaminase (ALT) changes in Chronic Hepatitis B (CHB) patients: Analysis of Phase 2b study to inform Phase 3 decision-making
Ahmed Nader
Poster (3592/ SAT441)
Combination treatment of a PAPD5/7 inhibitor with an antisense oligonucleotide bepirovirsen with concurrent dosing shows additive HBsAg decreases in the AAV-HBV mouse model
Martin Leivers
Poster (3590/ SAT451)Combination treatment of a PAPD5/7 inhibitor with an antisense oligonucleotide bepirovirsen with concurrent dosing shows additive HBsAg decreases in the AAV-HBV mouse model