吉利德将在肝脏会议上展示关于肝病治疗和诊断的广泛新数

StephenW

Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018
today

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct 11, 2018--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that data from the company’s liver disease research and development programs in nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection will be presented at The Liver Meeting ® 2018 in San Francisco from November 9-13, 2018. The data reflect Gilead’s ongoing commitment to advancing the care of patients with serious liver diseases.

“Gilead has transformed the treatment of viral liver diseases with innovative medicines that have cured HCV and significantly improved treatment of HBV for millions around the world,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research & Development, Gilead Sciences. “Today, we are working to bring this expertise and commitment to other serious liver diseases with significant unmet medical needs, such as advanced fibrosis due to NASH and PSC – two diseases with no or limited treatment options.”

Advanced Fibrosis due to NASH

Individuals with advanced fibrosis, defined as bridging fibrosis (F3) or cirrhosis (F4), are at a significantly higher risk of liver-related mortality. Gilead is advancing multiple investigational compounds for the treatment of advanced fibrosis due to NASH. Data being presented at the meeting further elucidate the potential role and safety profile of three compounds in development.
The non-steroidal FXR agonist GS-9674 leads to significant reductions in hepatic steatosis, serum bile acids, and liver biochemistry in a Phase 2, randomized, placebo-controlled trial of patients with NASH (poster #0736) Hepatic metabolomics and plasma microRNA analysis of combinations of an ASK1 inhibitor, an ACC inhibitor, and an FXR agonist in the rat choline-deficient high fat diet model reveal reductions in oxidative stress, inflammation and fibrosis (poster #1265)

Currently, liver biopsy is the standard method to diagnose advanced fibrosis due to NASH. This invasive and costly procedure presents challenges to appropriate diagnosis and treatment. Data being presented at The Liver Meeting describe the potential role and sequence of noninvasive tests in the diagnosis of advanced fibrosis due to NASH and patient-reported outcomes from two global Phase 3 trials evaluating the investigational ASK1 inhibitor selonsertib.
Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data from STELLAR clinical trials (late-breaking poster #LB-10) Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib (poster #1674) Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to NASH (poster #1683) Advanced fibrosis based on noninvasive tests in NASH is associated with impairment of patient-reported outcomes (poster #1991)

PSC

Data will be presented from a Phase 2 trial evaluating the investigational non-steroidal farnesoid X receptor (FXR) agonist GS-9674 in PSC. PSC is a rare and chronic condition that causes inflammation and scarring of the bile ducts, which can lead to liver failure. There are limited treatment options currently available for patients with PSC.
The non-steroidal FXR agonist GS-9674 improves liver biochemistry and decreases serum bile acids in patients with PSC: A Phase 2, randomized, placebo-controlled trial (oral presentation #0043)

HBV Functional Cure

Data will also be presented from Gilead’s ongoing program directed at achieving a functional cure for HBV by maintaining viral suppression without ongoing therapy. GS-9688, an investigational oral selective toll-like receptor 8 (TLR8) agonist, is the subject of several studies to be presented, including first-in-human clinical results and Phase 1b results from evaluation in patients with chronic hepatitis B.
First in human study of GS-9688, an oral Toll-like Receptor 8 (TLR8) agonist, in healthy volunteers: assessment of safety, tolerability, pharmacokinetics, pharmacodynamics and food effect (poster #0390) Pharmacodynamic response to oral administration of the selective toll-like receptor 8 agonist GS-9688 in healthy volunteers (poster #0456) Safety, pharmacokinetics and pharmacodynamics of oral TLR8 agonist GS-9688 in patients with chronic hepatitis B: a randomized, placebo-controlled, double-blind Phase 1b study (poster #0401)

GS-9674, selonsertib and GS-9688 are investigational compounds and are not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Their safety and efficacy have not been established.

StephenW

吉利德将在肝脏会议上展示关于肝病治疗和诊断的广泛新数据2018年
今天

福斯特城，加利福尼亚州 - （BUSINESS WIRE） - 2018年10月11日 - 吉利德科学公司（Nasdaq：GILD）今天宣布，计划从公司的研发肝病酒精性脂肪性肝炎数据（NASH），原发性硬化性胆管炎（PSC），乙型肝炎病毒（HBV）感染和丙型肝炎病毒（HCV）感染会在肝脏会议®2018旧金山，距离11月9-13日提出，2018年的数据反映Gilead公司推进正在进行的承诺护理严重肝病患者。

“吉利德已经改变了病毒性肝脏疾病的创新药物已治愈丙型肝炎病毒，并显着数百万世界各地的改善治疗乙肝的治疗，”约翰说McHutchison，AO，医学博士，首席科学官，研究与发展，Gilead Sciences公司的负责人。 “今天，我们正在努力把ESTA的专业知识和承诺，严重的肝脏疾病等显著未被满足的医疗需求有了，如晚期肝纤维化是由于纳什和PSC - 两种疾病有限或没有治疗选择”

由NASH引起的晚期纤维化

个人晚期肝纤维化，定义为桥接纤维化（F3）或肝硬化（F4），是在肝脏显着相关死亡率的风险较高。吉利德正在推进多种研究化合物用于治疗NASH引起的晚期纤维化。会议上提供的数据进一步阐明了三种化合物在开发中的潜在作用和安全性。
非甾体FXR激动剂GS-9674导致一个阶段的脂肪肝，胆汁血酸和肝脏生化显著减少2，患者的随机，安慰剂对照试验纳什（海报＃0736）肝代谢和血浆微小RNA分析的抑制剂，ACC抑制剂，并在氧化应激减少大鼠胆碱缺乏饮食高脂肪模型的FXR激动剂的组合的ASK1揭示，炎症和纤维化（海报＃1265）

目前，肝脏活检是诊断NASH引起的晚期纤维化的标准方法。这种侵入性和昂贵的程序对适当的诊断和治疗提出了挑战。数据被呈现在肝脏会议描述的非侵入性测试和序列中的潜在作用在晚期纤维化由于NASH和患者报告结果的诊断从两个3期试验评估整体研究性selonsertib ASK1抑制剂。
从因NASH STELLAR临床试验（的最新海报＃LB-10）定期提供无创性检查鉴别肝纤维化的相位数据ASK1抑制剂3个STELLAR试验：采用无创性检查算法能够准确地确定患者的肝纤维化是由于NASH selonsertib结果（海报＃1674）在晚期肝纤维化患者的患者报告结果由于NASH（海报＃1683）的基础上在NASH无创性检查肝纤维化严重损害与患者报告的差不多（海报＃1991）相关的减值

PSC

数据将来自评估PSC中非甾体类研究法尼醇X受体（FXR）激动剂GS-9674的2期试验。 PSC是一种罕见的慢性疾病，可导致胆管炎症和瘢痕形成，从而导致肝功能衰竭。目前PSC患者的治疗选择有限。
的非甾体激动剂FXR GS-9674改善肝生物化学和血清胆汁酸降低了患者与PSC：第2阶段，随机，安慰剂对照试验（口头报告＃0043）

HBV功能性治疗

数据将来自吉利德正在进行的计划，该计划旨在通过维持病毒抑制而无需持续治疗来实现HBV的功能治愈。 GS-9688，口服试验用选择性toll样受体8（TLR8）激动剂，是若干研究的主题将被呈现，零食包括先入人体临床结果和从阶段1b的评价结果​​在慢性乙型肝炎
首先，在GS-9688的人体研究，口服的Toll样受体8（TLR8）激动剂，在健康志愿者中：安全性，耐受性，药动学，药效学及食物影响（海报＃0390），以选择性的口服药效反应评估toll样受体8激动剂GS-9688在健康志愿者（海报＃0456）的安全，药代动力学和口服TLR8激动剂GS-9688的药效学与慢性乙肝患者：一项随机，安慰剂对照，双盲1b期研究（海报＃0401）

GS-9674，selonsertib和GS-9688是研究化合物，未经美国批准。食品药品管理局（FDA）或任何其他监管机构。他们的安全性和有效性尚未确定。