Galectin Therapeutics Presents Clinical Data on NAVIGATE Trial for Esophageal Varices in MASH Cirrhosis at AASLD 2024
Galectin Therapeutics Presents Clinical Data on NAVIGATE Trial for Esophageal Varices in MASH Cirrhosis at AASLD 2024
Approximately one third of patients screened had detectable esophageal varices on EGD, highlighting screening needs.Galectin Therapeutics presents NAVIGATE trial findings on portal hypertension in MASH cirrhosis at AASLD 2024. Results expected December 2024.
galectin therapeutics在AASLD 2024年会上发布了NAVIGATE试验在MASH肝硬化患者中与门脉高压相关的研究结果。预计结果将于2024年12月公布。
Quiver AI Summary
Quiver AI 概要
Galectin Therapeutics, Inc. has announced updates on the NAVIGATE trial, which is focused on treating patients with MASH cirrhosis and portal hypertension, at the AASLD 2024 Liver Meeting. The trial utilizes non-invasive tests and adheres to the latest guidelines for portal hypertension. Key findings indicate that a centralized review system can effectively evaluate esophagogastoduodenoscopy (EGD) results in a large multi-center setting and that around a third of trial participants with MASH cirrhosis have undetected esophageal varices, reinforcing the necessity for routine screening in this population. The trial's readout is expected in December 2024, and several posters detailing patient baseline characteristics and findings from the EGD evaluations will be presented at the conference. Galectin's lead drug, belapectin, is aimed at improving outcomes in chronic liver diseases and has received Fast Track designation from the FDA.
galectin therapeutics公司宣布了关于NAVIGATE试验的更新，该试验致力于治疗MASH肝硬化和门脉高压患者，在AASLD 2024肝病大会上进行了介绍。该试验采用非侵入性测试，并遵循最新的门脉高压指南。关键发现显示出一个集中审查系统可以有效评估大型多中心环境下食管胃十二指肠镜检查结果，大约三分之一的MASH肝硬化试验参与者未检测到食管静脉曲张，强调了在此人群中进行常规筛查的必要性。预计该试验的结果将于2024年12月公布，并将在会议上展示几份关于患者基线特征和食管胃十二指肠镜检查结果的海报。galectin的主力药物belapectin旨在改善慢性肝病患者的预后，并已获得FDA的快速通道认定。
Potential Positives
潜在的积极因素
- Galectin Therapeutics is presenting significant findings from the NAVIGATE trial at a prestigious event, highlighting the ongoing commitment to advancing clinical research in a high-unmet-need population.
- The trial's centralized evaluation system is noted for its effectiveness, which could lead to more consistent assessments of critical endpoints in portal hypertension trials.
- Approximately one-third of screened patients were found to have esophageal varices, emphasizing the necessity for reliable screening methods, which may enhance treatment opportunities and patient outcomes.
- The upcoming NAVIGATE trial readout is on track for December 2024, maintaining investor interest and providing a clear timeline for anticipated results.
- galectin therapeutics正在一个知名活动中展示了NAVIGATE试验的重要发现，突显了继续致力于在高未满足需求人群中推进临床研究。
- 该试验的集中评估系统因其有效性而闻名，这可能导致对门脉高压试验中关键终点的更一致评估。
- 大约三分之一的被筛选患者被发现患有食管静脉曲张，强调了可靠筛查方法的必要性，这可能增强治疗机会和患者预后。
- 即将到来的NAVIGATE试验结果公布计划于2024年12月完成，保持投资者的兴趣，并为预期结果提供明确的时间表。
Potential Negatives
潜在负面影响
- Approximately one-third of patients with MASH cirrhosis and portal hypertension screened for the NAVIGATE trial had incidental findings of varices, indicating a potential oversight in the patient management and screening processes.
- The reliance on a centralized evaluation system for assessing esophageal and gastric varices may raise concerns about the consistency and effectiveness of the evaluations across multiple centers.
- Advancement of additional clinical programs is largely dependent on finding a suitable partner, which may indicate challenges in securing funding or collaboration for further developments.
- MASH肝硬化和门脉高压患者大约三分之一接受NAVIGATE试验进行筛查，发现静脉曲张的情况，这表明患者管理和筛查过程可能存在潜在的疏忽。
- 依赖集中评估系统评估食管和胃静脉曲张可能引起对于多个中心评估的一致性和有效性的担忧。
- 进一步的临床计划的推进在很大程度上取决于找到合适的合作伙伴，这可能表明在确保进一步发展的资金或合作方面存在挑战。
FAQ
FAQ
What is the NAVIGATE trial focused on?
NAVIGATE试验的焦点是什么？
The NAVIGATE trial studies belapectin for preventing esophageal varices in patients with MASH cirrhosis and portal hypertension.
NAVIGATE试验研究了belapectin在MASH肝硬化和门脉高压患者中预防食管静脉曲张的效果。
What percentage of patients had varices during screening?
在筛查期间有多少百分比的患者出现静脉曲张？
Approximately one third of patients screened had detectable esophageal varices on EGD, highlighting screening needs.
大约三分之一的接受筛查的患者在食管镜检中检测到存在食管静脉曲张，突显出筛查的必要性。
When is the NAVIGATE trial readout expected?
NAVIGATE试验的结果预计何时公布？
The NAVIGATE trial readout is scheduled for December 2024.
NAVIGATE试验结果计划于2024年12月公布。
What was presented at the AASLD annual meeting?
AASLD年会上有哪些内容？
Three posters detailing clinical data from the NAVIGATE trial were presented at the AASLD annual meeting.
在AASLD年会上，有三篇海报展示了NAVIGATE试验的临床数据。
What is belapectin's significance in the trial?
在试验中，belapectin有何重要性？
Belapectin is a galectin-3 inhibitor with Fast Track designation for treating MASH cirrhosis, addressing a major medical need.
Belapectin是一种galectin-3抑制剂，获得了用于治疗MASH肝硬化的快速通道资格，满足了重大医疗需求。
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
免责声明：这是由GlobeNewswire分发的新闻稿的人工智能生成摘要。用于总结这份稿件的模型可能会出错。请在这里查看完整发布。
$GALT Insider Trading Activity
$GALt内幕交易活动
$GALT insiders have traded $GALT stock on the open market 8 times in the past 6 months. Of those trades, 8 have been purchases and 0 have been sales.
$GALt内部人员在过去6个月内已经在公开市场上进行了8次交易。其中，有8次是购买，0次是销售。
Here's a breakdown of recent trading of $GALT stock by insiders over the last 6 months:
以下是$GALt内部人员在过去6个月内最近交易的详细情况：
- KARY ELDRED purchased 500 shares.
- KEVIN D FREEMAN has traded it 4 times. They made 4 purchases, buying 13,800 shares and 0 sales.
- RICHARD A. JR. ZORDANI has traded it 3 times. They made 3 purchases, buying 3,500 shares and 0 sales.
- KARY ELDRED购买了500股。
- KEVIN D FREEMAN已经交易了4次。他们进行了4次购买，购买了13,800股，销售了0股。
- RICHARD A. JR. ZORDANI已经交易了3次。他们进行了3次购买，购买了3,500股，销售了0股。
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
要跟踪内部交易，请查看Quiver Quantitative的内部交易特斯拉-仪表。
$GALT Hedge Fund Activity
$GALt对冲基金活动
We have seen 33 institutional investors add shares of $GALT stock to their portfolio, and 28 decrease their positions in their most recent quarter.
我们已经看到33家机构投资者在他们最近的季度add股票$GALt到他们的投资组合中，而有28位减少了他们的头寸。
Here are some of the largest recent moves:
以下是一些最近最大的交易动态：
- SUSQUEHANNA INTERNATIONAL GROUP, LLP removed 120,868 shares (-59.7%) from their portfolio in Q3 2024
- NORTHERN TRUST CORP added 107,306 shares (+84.5%) to their portfolio in Q3 2024
- QUBE RESEARCH & TECHNOLOGIES LTD removed 69,045 shares (-100.0%) from their portfolio in Q2 2024
- SQUAREPOINT OPS LLC removed 56,639 shares (-67.4%) from their portfolio in Q3 2024
- OSAIC HOLDINGS, INC. added 56,100 shares (+5.0%) to their portfolio in Q3 2024
- MAN GROUP PLC removed 53,045 shares (-80.7%) from their portfolio in Q3 2024
- BLACKROCK, INC. added 43,341 shares (+2.8%) to their portfolio in Q3 2024
- SUSQUEHANNA国际集团LLP在2024年Q3中从他们的投资组合中移除了120,868股股票（-59.7%）。
- NORTHERN TRUSt CORP在2024年Q3中向他们的投资组合中添加了107,306股股票（+84.5%）。
- QUBE研究与技术有限公司在2024年Q2中从他们的投资组合中移除了69,045股股票（-100.0%）。
- SQUAREPOINT OPS LLC在2024年Q3中从他们的投资组合中移除了56,639股股票（-67.4%）。
- OSAIC HOLDINGS, INC.在2024年Q3中向他们的投资组合中添加了56,100股股票（+5.0%）。
- MAN GROUP PLC在2024年Q3中从他们的投资组合中移除了53,045股股票（-80.7%）。
- 黑石投资公司在2024年第三季度将43,341股股票（+2.8%）添加到其投资组合中
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
要追踪对冲基金的股票组合，请查看Quiver Quantitative的机构持股仪表板。
Full Release
全面发布
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Patient population for the NAVIGATE trial is based on non-invasive tests and clinical criteria utilizing latest treatment guidelines for portal hypertension in MASH cirrhosis
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Blinded central review system can be effectively set-up for evaluation of esophagogastoduodenoscopy (EGD) in large multi-center trial of patients with MASH cirrhosis and portal hypertension, facilitating utilization of this outcome as a critical endpoint in portal hypertension trials
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Approximately a third of patients with MASH cirrhosis and portal hypertension (PH) screened for the NAVIGATE trial had the incidental finding of varices on EGD, highlighting the need for screening EGDs in these patients
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NAVIGATE trial readout on track for December 2024
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NAVIGATE试验的患者人群基于非侵入性检查和临床标准，利用最新的门脉高压治疗指南，适用于MASH肝硬化
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对MASH肝硬化和门脉高压患者进行大型多中心试验的食管胃十二指肠镜（EGD）评估可有效建立起失明中央审查系统，促进这种结果作为门脉高压试验的重要终点的利用
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约三分之一的MASH肝硬化和门脉高压（PH）患者在接受NAVIGATE试验筛查时，在EGD检查中意外发现静脉曲张，凸显了需要在这些患者中进行筛查性EGD检查
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NAVIGATE试验的结果预计将于2024年12月出炉
NORCROSS, Ga., Nov. 18, 2024 (GLOBE NEWSWIRE) --
Galectin Therapeutics, Inc.
(NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today announced the presentation of three posters on the ongoing NAVIGATE trial in patients with MASH cirrhosis and portal hypertension at the American Association for the Study of Liver Diseases (AASLD)'s annual meeting 2024 Liver Meeting, being held November 15-19, 2024 in San Diego, California.
美国佐治亚州诺克罗斯，2024年11月18日（环球新闻） --
galectin therapeutics公司
（纳斯达克：GALT）是致力于研发针对凝集素蛋白的治疗药物的领先开发者，今天宣布在美国肝病研究协会（AASLD）2024年度会议上，就持续进行中的MASH肝硬化和门脉高压NAVEgate试验展示了三份海报，此次会议将于2024年11月15日至19日在加利福尼亚州圣迭戈举行。
"We are excited to share latest clinical data from our ongoing NAVIGATE trial of belapectin for the prevention of esophageal varices in patients with MASH cirrhosis and portal hypertension. We show that a centralized evaluation system can be designed for consistent and effective assessment of esophageal and gastric varices, which is critical for advancing clinical research in this population with high unmet need. We also provide an in depth look at baseline characteristics of the patient enrolled in our NAVIGATE trial," said Khurram Jamil, M.D., Chief Medical Officer of Galectin Therapeutics. "In another key finding, our research reveals that among patients with compensated MASH cirrhosis with reduced platelet counts and radiologic signs of portal hypertension, approximately one-third have detectable esophageal varices upon screening. These findings underscore the need for reliable screening and targeted therapies in this vulnerable patient population. These clinical data are of great importance as we look forward to sharing the readout of our NAVIGATE trial before the end of the year."
“我们很高兴分享我们正在进行的belapectin用于预防MASH肝硬化和门脉高压患者食管静脉曲张的最新临床数据。我们展示了一个中心化评估系统可以为食管和胃静脉的一致和有效评估而设计，这对于推动高度未满足需求人群的临床研究至关重要。我们还深入研究了参与我们NAVEgate试验的患者的基线特征，” Galectin Therapeutics的首席医疗官Khurram Jamil博士说道。“在另一个关键发现中，我们的研究揭示出在血小板计数减少和门脉高压放射学征象的补偿性MASH肝硬化患者中，约三分之一在筛查时可检测到食管静脉曲张。这些发现强调了在这些易受伤害患者群体中的可靠筛查和定向治疗的必要性。随着我们期待在年底之前分享NAVEgate试验结果，这些临床数据具有重要意义。”
The following posters highlighting clinical data will be presented at the "Portal Hypertension and Other Complications of Cirrhosis" session taking place 8:00 am – 5:00 pm on November 18, 2024:
以下是突出临床数据的海报，将在2024年11月18日上午8:00至下午5:00举办的“门脉高压和肝硬化的其他并发症”专题会议上展示：
Poster #4118:
Evaluation of esophageal and gastric varices in cirrhotic patients with portal hypertension: a central evaluation system for clinical research.
Presenter:
Naim Alkhouri, M.D., Arizona Liver Health, Chandler, AZ.
海报#4118：
对门脉高压肝硬化患者食管和胃静脉的评估：用于临床研究的中心化评估系统。
报告人：
亚利桑那州钱德勒的亚利桑那肝脏健康中心Naim Alkhouri博士。
Poster #4063:
Baseline patients' characteristics from NAVIGATE, a seamless adaptive Phase 2b/3 trial of Belapectin in MASH cirrhosis and portal hypertension.
Presenter:
Khurram Jamil, M.D., Chief Medical Officer, Galectin Therapeutics.
海报#4063：
NAVIGATE项目的基线患者特征，这是一个针对MASH肝硬化和门脉高压的贝拉佩汀无缝适应性2b/3期试验。
报告人：
Khurram Jamil博士，Galectin Therapeutics首席医学官。
Poster #4125:
In patients with compensated MASH cirrhosis with platelet count < 150,000/μL and radiologic findings of portal hypertension, a third are identified with esophageal varices on screening Esophago-Gastroduodenoscopy.
Presenter:
Laura Ladron deGuevar, M.D., CIAID - Centro de Investigacion y Atencion Integral Durango, S.C.
海报#4125：
在血小板计数＜150,000/μL且具有门脉高压影像学发现的代偿性MASH肝硬化患者中，三分之一通过筛查食管胃十二指肠镜检查诊断为食管静脉曲张。
报告人：
Laura Ladron deGuevar博士，CIAID - Centro de Investigacion y Atencion Integral Durango, S.C.
The three abstracts are available for viewing by attendees on the AASLD website and will also be featured in the October supplement to the AASLD journal,
Hepatology
.
AASLD网站上的参会者可以查看三个摘要，并且这些摘要也将在AASLD期刊的十月增刊中呈现。
Hepatology
.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin's lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical needs and a significant drug development opportunity. Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at
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关于galectin therapeutics公司
Galectin Therapeutics致力于开发新型疗法，以改善患有慢性肝病和癌症的患者的生活。 Galectin的首席药物belapectin是一种基于碳水化合物的药物，可抑制直接参与多种炎症、纤维化和恶性疾病的galectin-3蛋白质，在这方面，它已被美国食品和药物管理局列为快速通道。首席研发项目是代谢紊乱相关的脂肪肝炎（曾称为非酒精性脂肪肝炎或NASH）并发肝硬化，这是与MASH相关纤维化的最高级形式。肝硬化是最紧迫的医疗需求之一，也是重要的药物开发机会。其他开发项目涉及用于治疗晚期头颈癌和其他恶性肿瘤的联合免疫疗法。这些额外临床项目的推进在很大程度上取决于找到合适的合作伙伴。 Galectin希望利用其广泛的科学和开发专业知识以及与外部资源的建立的关系，实现成本效益高和高效的开发。可在此处获取更多信息。
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Company Contact:
公司联系人：
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
Jack Callicutt, 首席财务官
(678) 620-3186
ir@galectintherapeutics.com
Investors Relations Contacts:
Kevin Gardner
kgardner@lifesciadvisors.com
投资人关系联系方式:
Kevin Gardner
kgardner@lifesciadvisors.com
Chris Calabrese
ccalabrese@lifesciadvisors.com
Chris Calabrese
ccalabrese@lifesciadvisors.com
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics' galectin-3 inhibitor belapectin.
galectin therapeutics及其关联标识是galectin therapeutics公司的注册商标。belapectin是Galectin Therapeutics的galectin-3抑制剂belapectin的美国通用名。
