数据将于11月18日星期一在圣地亚哥举行的美国肝脏疾病研究协会（AASLD）肝脏会议?2024上作为迟来的海报公布。
与安慰剂相比，LEGEND通过显著降低兰尼布兰诺组和兰尼布兰诺联合恩格列净组的HbA1c水平达到了主要疗效终点。
50%的患者在单独使用兰尼布诺或联合使用恩格列净治疗后第24周的HbA1c水平低于6.5%。
单独使用兰菲布诺的患者中有58%和联合使用兰菲布诺的患者中有80%在第24周时HbA1c至少下降了1%，而安慰剂组为0%。
肝功能检查肝纤维化标记物心脏组标记物代谢健康包括HOMA-IR， hsCRP，铁蛋白，脂质谱和脂肪lanifbranor单独使用或与恩格列净联合使用时，Nectin水平也有所提高。
在一部分服用兰菲布诺的患者中观察到体重增加，而在兰菲布诺与恩格列净联合治疗的患者中没有观察到体重增加。
岱克斯（法国），长岛市（美国纽约），2024年11月15日- Inventiva(欧元
该公司是一家临床阶段的生物制药公司，专注于开发用于治疗me的口服小分子疗法
代谢功能障碍相关脂肪性肝炎（“MASH”），也称为非酒精性脂肪性肝炎（“NASH”），以及其他具有显著未满足医疗需求的疾病，今天宣布提交LEGEND的最终分析，2期证明
除临床试验外
兰菲布诺联合恩格列净治疗糖尿病合并2型糖尿病（T2D）的疗效评价数据将于下周公布
2024年11月18日，美国肝病研究协会（AASLD）肝脏会议（the Liver Meeting?）在加州圣地亚哥举行。
Inventiva首席医疗官Michael Cooreman博士表示：“我们很高兴在肝脏会议上展示我们的LEGEND研究结果。我们相信，lanifibranor联合empagliflozin的结果不仅证实了lanifibranor作为单一疗法治疗MASH和2型糖尿病患者的益处，而且还支持了该患者群体联合治疗的治疗范例。”
Nezam（“Nid”）Afdhal博士，贝斯以色列女执事医疗中心胃肠病学主任，哈佛医学院医学教授，说：“经常被忽视的是，MASH是胰岛素抵抗的肝脏表现。来自LEGEND研究的令人兴奋的新数据，评估了lanifibranor和empagliflozin的组合，证实了lanifibranor具有靶向疾病潜在生物学的潜力。此外，LEGEND应该减轻对体重增加的担忧，因为这可以通过sGLT2抑制剂或其他治疗如GLP-1激动剂来控制，这是T2D治疗的选择。”
ii期研究LEGEND纳入了筛查时血红蛋白A1c （HbA1c）在7-10%之间的MASH和T2D患者。兰尼布洛诺和安慰剂的试验是双盲的，但兰尼布洛诺和恩格列净的联合试验是开放标签的。
该研究达到了HbA1c改善的主要疗效终点，两组治疗均达到了HbA1c改善的主要疗效终点，单抗和联合恩格列净治疗的患者的HbA1c水平显著降低，50%的患者在第24周达到HbA1c低于6.5% （p<0.001）。此外，58%单独使用兰菲布诺的患者和80%使用联合治疗的患者在第24周时HbA1c至少下降1%，而安慰剂组为0%。
此外，通过磁共振成像-质子密度脂肪分数（MRI-PDFF）以及cT1、-86和-75 ms测量的复合MASH活性和纤维化，lanifbranor单独治疗和联合恩格列净治疗的患者肝脏脂肪变性分别显著改善-49%和-41%。
此外，与安慰剂组相比，使用兰尼布兰诺（p=0.009）和兰尼布兰诺联合恩帕列净治疗的T2D和MASH患者的脂联素水平平均增加了3倍（p=0.004）。
在体重方面，只服用兰尼布兰诺组的体重增加了3.6%，而服用兰尼布兰诺和恩格列净组的体重保持稳定。重要的是，在单独使用兰菲布诺或联合使用恩格列净的两组患者中，内脏腹部脂肪与皮下脂肪的比例都有所下降（分别为- 5%和-18%，而安慰剂组为+2%），反映了从促炎内脏脂肪向代谢健康脂肪组织的转变
肝功能测试（ALT， AST， GGT）和肝纤维化标志物（TIMP-1, P3NP, Pro-C3）在lanifbranor的治疗下改善，无论是单独使用还是与恩格列净联合使用。其他心脏代谢健康指标，如胰岛素敏感性（HOMA-IR）、炎症（hs-CRP）、铁蛋白、血糖和脂质水平（HDL-C、甘油三酯），在两个治疗组中也显示出改善。
讲座的详情如下：
Inventiva将于11月16日（周六）至11月18日（周一）在1445号展位展出。
一个布特Inventiva
Inventiva是一家临床阶段的生物制药公司，专注于研究和开发口服小分子疗法，用于治疗MASH/NASH患者和其他未满足医疗需求的疾病。该公司在靶向核受体、转录因子和表观遗传调节的化合物领域拥有强大的专业知识和经验。Inventiva目前正在推进一个临床候选药物，有两个临床前项目，并继续探索其他开发机会，以增加其管道。
Inventiva的主要候选产品lanifibranor目前正在进行关键的3期临床试验NATiV3，用于治疗成人MASH/NASH（一种常见的进行性慢性肝病）。
Inventiva的产品线还包括odiparcil，一种用于治疗成人MPS VI患者的候选药物。作为Inventiva决定将临床工作重点放在lanifbranor开发上的一部分，该公司暂停了与odiparcil相关的临床工作，并正在审查有关其潜在进一步开发的可用选项。Inventiva也在为其Hippo信号通路项目选择候选药物。
公司拥有一支约90人的科学团队，在生物学、药物和计算化学、药代动力学和药理学以及临床开发等领域拥有深厚的专业知识。它拥有约24万个药理学相关分子的广泛文库，其中约60%是专有的，以及一个全资拥有的研发设施。
Inventiva是一家上市公司，在巴黎泛欧交易所B区上市（股票代码：IVA， ISIN: FR0013233012），在美国纳斯达克全球市场上市（股票代码：IVA）。www.inventivapharma.com
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重要的通知
本新闻稿附在1995年《私人证券诉讼改革法案》的安全港条款中包含“前瞻性陈述”。除历史事实陈述外，本新闻稿中包含的所有陈述均为前瞻性陈述。
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There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on enrollment or the ultimate impact on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva's ability to obtain financing and to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require holds and/or amendments to Inventiva's clinical trials, Inventiva's expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH/NASH may not be realized and may not support the approval of a New Drug Application, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners' control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's and its partners' business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, impacts and potential impacts on the initiation, enrollment and completion of Inventiva's and its partners' clinical trials on anticipated timelines and the state of war between Israel and Hamas and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including global inflation, rising interest rates, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.
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附件
发明- PR - lanifbranor AASLD延迟断路器- EN - 1115 2024
