GSK plc (LSE/NYSE: GSK) today announced positive headline results of GLISTEN, the ongoing global phase III clinical trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), in adults with cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease..

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布了GLISTEN的正面头条结果，GLISTEN是一项正在进行的全球III期临床试验，该试验评估了利奈昔巴特（一种回肠胆汁酸转运蛋白（IBAT）的研究性靶向抑制剂）治疗与原发性胆汁性胆管炎（PBC）（一种罕见的自身免疫性肝病）相关的胆汁淤积性瘙痒症（无情的瘙痒）。。

GLISTEN met its primary endpoint, with linerixibat resulting in an improvement in itch, as demonstrated by a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo. The trial recruited PBC patients with moderate to severe itch, who were receiving stable doses of guideline-suggested therapies for pruritus, or were treatment naïve, or had been previously treated.

GLISTEN达到了主要终点，与安慰剂相比，Linerixibat可改善瘙痒症状，24周内每月瘙痒评分与基线相比有统计学意义的显著降低。该试验招募了中度至重度瘙痒的PBC患者，他们正在接受指南建议的稳定剂量的瘙痒治疗，或者是治疗新手，或者曾经接受过治疗。

The preliminary safety results are generally consistent with those seen in prior studies of linerixibat. Further analysis of these data is ongoing..

初步的安全性结果与之前的莱尼西巴研究结果基本一致。对这些数据的进一步分析正在进行中。

Kaivan Khavandi, SVP & Global Head, Respiratory/Immunology R&D, GSK, said: “Linerixibat has the potential to be the first global therapy specifically developed to treat itch in PBC. These positive data suggest that it could have a place in supporting patients whose quality of life is significantly affected in multiple ways by persistent itching.”.

GSK呼吸/免疫学研发高级副总裁兼全球负责人Kaivan Khavandi说：“利奈昔巴特有可能成为第一种专门用于治疗PBC瘙痒的全球疗法。这些积极数据表明，它可能在支持持续瘙痒以多种方式显着影响生活质量的患者方面占有一席之地。”。

People who have been diagnosed with PBC will reach 510,000 globally by 2030, and more than 240,000 people will experience relentless itch requiring treatment, representing a significant unmet need. 1,2,3,4 Current guideline suggested therapies available for cholestatic pruritus are inadequate, with known limited impact on itch, and poor tolerability.

到2030年，全球被诊断患有PBC的人数将达到51万，超过24万人将经历需要治疗的持续瘙痒，这是一个严重的未满足需求。。

5,6 PBC is a rare disease of the bile ducts that primarily affects women and can cause liver damage and possible liver failure if untreated. One of the most common symptoms is constant, relentless itching or skin-crawling sensations, as well as fatigue that is often made worse by itching at night. The disease currently has no cure..

5,6 PBC是一种罕见的胆管疾病，主要影响女性，如果不治疗，可能导致肝损伤和肝衰竭。最常见的症状之一是持续不断的，无情的瘙痒或皮肤爬行的感觉，以及经常因夜间瘙痒而加剧的疲劳。这种疾病目前无法治愈。。

Carol Roberts, President, The PBCers Organization, said: “The itch associated with PBC for many patients is unrelenting and often severe but is a symptom that is frequently overlooked or dismissed. It has a significant impact on quality of life and mental health for people with PBC. The potential of a treatment option that addresses a root cause of itch answers a previously unmet need for people with PBC.'.

PBCers组织主席卡罗尔·罗伯茨（CarolRoberts）表示：“对许多患者来说，与PBC相关的瘙痒是无情的，通常很严重，但这是一种经常被忽视或忽视的症状。它对PBC患者的生活质量和心理健康有重大影响。解决瘙痒根本原因的治疗方案的潜力回答了PBC患者以前未得到满足的需求。”。

The full results of GLISTEN will be presented at a future scientific congress. Linerixibat is currently not approved anywhere in the world; it has been granted Orphan Drug Designation in both the US and EU.

GLISTEN的全部结果将在未来的科学大会上公布。Linerixibat目前尚未在世界任何地方获得批准；它已被美国和欧盟授予孤儿药称号。

About cholestatic pruritus in primary biliary cholangitis

原发性胆汁性胆管炎胆汁淤积性瘙痒症

In primary biliary cholangitis (PBC), a cholestatic liver disease, bile flow from the liver is disrupted. The resulting excess bile acids in circulation are thought to play a causal role in cholestatic pruritus, an internal itch that cannot be relieved by scratching. Pruritus can occur at any stage of PBC disease and is experienced by up to 90% of people living with PBC.4 The first line treatment for PBC controls disease in approximately 70% of patients, but does not reduce the severity or impact of the pruritus.7 Cholestatic pruritus is a serious condition that can be debilitating, with patients experiencing sleep disturbance, fatigue, impaired quality of life and even sometimes requiring liver transplantation in the absence of liver failure.4.

原发性胆汁性胆管炎（PBC）是一种胆汁淤积性肝病，从肝脏流出的胆汁被破坏。由此产生的循环中过量的胆汁酸被认为在胆汁淤积性瘙痒症中起因果作用，胆汁淤积性瘙痒症是一种无法通过抓挠缓解的内部瘙痒。瘙痒症可以发生在PBC疾病的任何阶段，高达90%的PBC患者都会经历瘙痒症[4]。PBC的一线治疗可以控制大约70%的患者的疾病，但不会降低瘙痒症的严重程度或影响[7]。胆汁淤积性瘙痒症是一种严重的疾病，可能会使人衰弱，患者会出现睡眠障碍，疲劳，生活质量受损，甚至有时需要在没有肝衰竭的情况下进行肝移植。

About linerixibat (GSK2330672)

关于利来昔布（GSK2330672）

Linerixibat is an ileal bile acid transporter (IBAT) inhibitor, a targeted oral agent with potential to treat cholestatic pruritus (itch) associated with the rare autoimmune liver disease known as primary biliary cholangitis (PBC). By inhibiting bile acid re-uptake, linerixibat aims to address a root cause of cholestatic pruritus.

利奈昔巴特是一种回肠胆汁酸转运蛋白（IBAT）抑制剂，是一种靶向口服药物，有可能治疗与罕见的自身免疫性肝病（称为原发性胆汁性胆管炎（PBC））相关的胆汁淤积性瘙痒（itch）。通过抑制胆汁酸的再摄取，利奈昔巴特旨在解决胆汁淤积性瘙痒症的根本原因。

The US Food and Drug Administration and the European Medicines Agency have granted orphan drug designation for linerixibat in the treatment of cholestatic pruritus associated with PBC..

美国食品和药物管理局（FDA）和欧洲药品管理局（European Medicines Agency）已批准利奈昔布（linerixibat）为孤儿药，用于治疗与PBC相关的胆汁淤积性瘙痒症。。

About the GLISTEN trial

关于GLISTEN审判

GLISTEN is an ongoing double-blind, randomised, placebo-controlled, phase III trial (NCT04950127; GSK study 212620) conducted in PBC patients with cholestatic pruritus. The primary analysis evaluated the efficacy (including impact on sleep) and safety of linerixibat compared with placebo. Participants with moderate to severe itch were enrolled.

GLISTEN是一项正在进行的双盲，随机，安慰剂对照的III期临床试验（NCT04950127；GSK研究212620），对胆汁淤积性瘙痒症的PBC患者进行。主要分析评估了与安慰剂相比，利奈昔布的疗效（包括对睡眠的影响）和安全性。中度至重度瘙痒的参与者被纳入研究。

The trial includes multiple arms where participants receive either linerixibat or placebo and have the potential to cross over at one point in the study. Primary and secondary outcome measures were assessed using the Numerical Rating Scale (NRS) for worst itch and itch-related sleep interference, and the PBC-40 questionnaire for quality of life.

该试验包括多组参与者，参与者接受利奈昔布或安慰剂，并有可能在研究中的某一点跨越。主要和次要结局指标使用数字评分量表（NRS）评估最严重的瘙痒和瘙痒相关的睡眠干扰，以及PBC-40生活质量问卷进行评估。

Stable use of guideline suggested anti-itch therapy was permitted. A small number of participants remain ongoing in an exploratory portion of the trial..

。少数参与者仍在进行试验的探索性部分。。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。