葛兰素史克将在 2022 年国际肝病大会上展示贝匹罗韦森治疗

StephenW

葛兰素史克将在 2022 年国际肝病大会上展示贝匹罗韦森治疗慢性乙型肝炎的 B-Clear IIb 期试验的新数据
仅供投资者和媒体使用

更多关于 Linerixibat 治疗原发性胆汁性胆管炎胆汁淤积性瘙痒的 II 期数据将被分享

发行：英国伦敦

GSK plc 将于 6 月 22 日至 26 日在伦敦举行的 2022 年欧洲肝脏研究协会国际肝脏大会上展示 12 篇摘要。葛兰素史克的存在将集中在两种新的研究性专业药物上，一种是用于慢性乙型肝炎（ CHB ）的反义寡核苷酸贝匹罗韦森，另一种是用于治疗原发性胆汁性胆管炎（ PBC ）胆汁淤积性瘙痒症的回肠胆汁酸转运蛋白（ IBAT ）抑制剂 linerixibat 。

葛兰素史克开发部高级副总裁 Chris Corsico 表示：“今年国际肝病大会上分享的新数据支持我们为有重大未满足医疗需求的患者提供新药的雄心，例如患有慢性乙型肝炎和原发性胆汁淤积性瘙痒症的患者。胆汁性胆管炎。我们期待与全球肝病学界合作，分享我们为这些患者取得的令人振奋的进展。”

贝匹罗韦森临床试验计划的更新

新的中期分析数据将从随机 B-Clear IIb 期试验中共享，该试验评估了贝匹罗韦森在慢性乙型肝炎病毒感染患者中使用和停用稳定核苷（酸）类似物治疗的有效性和安全性。该试验的数据将作为 6 月 25 日的 Late Breaker 口头报告会议的一部分（ILC 口头报告 # LB004A、LB004B）公布。

来自 bepirovirsen 开发计划的其他演示文稿包括：

    临床前证据表明贝匹罗韦森通过 Toll 样受体 8 (TLR8) 具有内在免疫刺激活性，与研究的临床疗效相关 (ILC 摘要 #3635/SAT439)
    贝匹罗韦森对 CHB 中乙型肝炎表面抗原 (HBsAg) 和丙氨酸转氨酶 (ALT) 变化同时影响的机制药代动力学和药效学模型（ILC 摘要#3592/SAT441）。

这些试验的数据反映了葛兰素史克致力于为慢性乙型肝炎患者开发功能性治疗并减轻患者疾病负担的雄心。
贝匹罗韦森

摘要名称演示者演示详细信息
贝匹罗韦森对慢性乙型肝炎病毒感染患者的疗效和安全性：随机 2b 期 B-Clear 研究的中期结果
袁文峰
口服（LB004A、LB004B）贝匹罗韦森对未接受稳定核苷（酸）类似物治疗的慢性乙型肝炎病毒感染患者的疗效和安全性：随机 2b 期 B-Clear 研究的中期结果

林成吉
海报 (3595/ SAT452)
贝匹罗韦森在慢性乙型肝炎病毒感染患者中接受稳定核苷（酸）类似物治疗的疗效和安全性：随机 2b 期 B-Clear 研究的中期结果

袁文峰
海报 (3629/ SAT453)
慢性乙型肝炎中 HBsAg 定量水平的评估——有针对性的文献综述

维拉·吉伦
海报 (1850/ SAT405)
IIb B-Clear 研究中慢性乙型肝炎病毒感染患者基线补体值的表征

詹妮弗·克雷默
海报 (1994/ THU390)
慢性乙型肝炎病毒感染患者的特征和肾功能：来自 2b 期 B-Clear 研究的基线数据

林成吉
海报 (1879/ THU389)
在国际多中心临床试验 B-Clear 中按指南定义的疾病阶段和/或灰色区域分布患者

林成吉
海报 (2127/ THU393)
Bepirovirsen 是一种抗乙型肝炎病毒 (HBV) 的反义寡核苷酸 (ASO)，在临床前通过 Toll 样受体 8 (TLR8) 具有内在的免疫刺激活性，与 2a 期研究的临床疗效相关

时铉游
海报 (3635/ SAT439)
贝匹罗韦森对慢性乙型肝炎（CHB）患者乙型肝炎表面抗原（HBsAg）和丙氨酸转氨酶（ALT）变化同时影响的机制药代动力学/药效学模型：分析2b期研究，为3期决策提供信息

艾哈迈德纳德
海报 (3592/ SAT441)
PAPD5/7 抑制剂与反义寡核苷酸贝匹罗韦森的联合治疗同时给药显示 AAV-HBV 小鼠模型中 HBsAg 的附加降低

马丁·莱弗斯
海报 (3590/SAT451)PAPD5/7 抑制剂与反义寡核苷酸贝匹罗韦森的联合治疗显示 AAV-HBV 小鼠模型中 HBsAg 的附加降低

StephenW

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