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Marea Therapeutics提供了公司进展的最新情况,包括MAR001心血管疾病2a期临床试验的阳性顶线结果,以及治疗肢端肥大症的第二个先导项目的披露

Marea Therapeutics Provides Update on Corporate Progress Including Positive Topline Results from Phase 2a Clinical Trial of MAR001 for Cardiovascular Disease and Disclosure of Second Lead Pipeline Program for the Treatment of Acromegaly

businesswire 等信源发布 2025-01-10 04:00

可切换为仅中文


SAN FRANCISCO--(

旧金山--(

BUSINESS WIRE

商业热线

)--Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardio-endocrine diseases, today provided an update on the company’s recent progress and upcoming milestones for 2025 in advance of the J.P.

)--Marea Therapeutics,Inc.,一家临床阶段的生物技术公司,利用人类遗传学的最新进展开发出一流的下一代心脏内分泌疾病药物,今天在J.P.之前提供了该公司最新进展和2025年即将到来的里程碑的最新信息。

Morgan 43.

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Annual Healthcare Conference, taking place from January 13-16, 2025 in San Francisco, CA.

2025年1月13日至16日在加利福尼亚州旧金山举行的年度医疗保健会议。

Since our launch in June 2024, Marea has made excellent progress across a number of areas,” said Josh Lehrer, M.D., M.Phil., FACC, chief executive officer of Marea. “

自2024年6月推出以来,Marea在多个领域取得了出色的进展,”Marea首席执行官Josh Lehrer,M.D.,M.Phil,FACC说道。“”

Based on positive results from our Phase 2a study that demonstrate clinically meaningful reductions in remnant cholesterol and triglycerides, we are preparing to advance MAR001 into Phase 2b clinical development in the first half of 2025. These data demonstrate the potential of MAR001 to address the untreated lipid and metabolic drivers of cardiovascular disease in high-risk patients.

基于我们2a期研究的积极结果,证明残余胆固醇和甘油三酯的临床意义降低,我们准备在2025年上半年将MAR001推进2b期临床开发。。

In addition, we announced our second lead pipeline program for the treatment of acromegaly with clinical development expected to initiate in the second half of 2025. Our strong pipeline progress, further fueled by the recent expansion of our management team and board of directors, positions us for an important 2025 as we seek to accelerate a new generation of medicines for cardiometabolic and endocrine diseases.”.

此外,我们宣布了第二个治疗肢端肥大症的领先管道计划,预计将于2025年下半年启动临床开发。我们的管理团队和董事会最近的扩张进一步推动了我们强大的管道进展,这为我们寻求加速开发新一代心脏代谢和内分泌疾病药物提供了重要的2025年。”。

Positive Phase 2a Topline Results for MAR001

MAR001的2a期Topline阳性结果

MAR001 is a potential first-in-class monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue.

MAR001是一种潜在的一流单克隆抗体,靶向ANGPTL4,ANGPTL4是一种在脂肪组织中高度表达的蛋白质。

The primary objective of Marea’s randomized, double-blind, placebo-controlled Phase 2a clinical trial was to characterize the safety and tolerability of multiple doses of MAR001 in participants with metabolic dysfunction. Secondary objectives were to describe the serum concentration of MAR001 at selected timepoints and to characterize the effect of MAR001 on triglyceride and remnant cholesterol metabolism following 12 weeks of treatment..

Marea的随机,双盲,安慰剂对照2a期临床试验的主要目的是表征多剂量MAR001在代谢功能障碍参与者中的安全性和耐受性。次要目标是描述MAR001在选定时间点的血清浓度,并表征治疗12周后MAR001对甘油三酯和残余胆固醇代谢的影响。。

The study enrolled 55 participants with hypertriglyceridemia (fasting TGs ≥150 and ≤499 mg/dL) randomized to MAR001 or placebo (blinded, 2:1 MAR001:Placebo). Ten participants were randomized to the 150 mg MAR001 arm, 17 participants to the 450 mg MAR001 arm, 9 participants to the 300 mg arm, and 19 participants to placebo..

该研究招募了55名高甘油三酯血症(空腹TGs≥150且≤499 mg/dL)的参与者,随机分配到MAR001或安慰剂(盲法,2:1 MAR001:安慰剂)。10名参与者被随机分配到150 mg MAR001组,17名参与者被分配到450 mg MAR001组,9名参与者被分配到300 mg组,19名参与者被分配到安慰剂组。。

Topline results showed meaningful reductions in remnant cholesterol and triglycerides. MAR001 at 300mg and 450mg demonstrated approximately 50% placebo-corrected remnant cholesterol lowering in the target population, predicting meaningful clinical benefit.

Topline结果显示残余胆固醇和甘油三酯显着降低。300mg和450mg的MAR001显示目标人群中安慰剂校正的残余胆固醇降低约50%,预测有意义的临床益处。

MAR001 was generally well tolerated. There have been no deaths or serious adverse events in any arm, and no adverse events leading to study drug discontinuation.

MAR001通常耐受性良好。任何一组都没有死亡或严重不良事件,也没有导致研究药物停药的不良事件。

The company plans on presenting a fuller data set at an upcoming medical meeting.

该公司计划在即将举行的医疗会议上提供更完整的数据集。

Marea expects to initiate a Phase 2b clinical trial with MAR001 in the first half of 2025.

Marea预计在2025年上半年启动MAR001的2b期临床试验。

These clinical data, coupled with the remarkable human genetic validation of ANGPTL4, the target for MAR001, establishes MAR001 as one of the most promising candidates advancing into late-stage development for treating residual cardiovascular risk in the patients who remain at highest risk despite aggressive standard of care therapies,” said Ethan Weiss, M.D., chief scientific officer of Marea..

这些临床数据,加上ANGPTL4(MAR001的目标)的显着人类基因验证,将MAR001确立为最有希望进入晚期发展的候选者之一,用于治疗尽管采用积极的标准护理疗法仍处于最高风险的患者的残余心血管风险,”Marea首席科学官伊桑·韦斯医学博士说。。

Second Lead Pipeline Program Announced: MAR002 for the Treatment of Acromegaly

宣布第二个主要管道计划:2002年3月用于治疗肢端肥大症

MAR002 is a potential first-in-class anti-growth hormone receptor (GHR) antibody being developed for acromegaly. Acromegaly is a life-shortening disease where much of the morbidity is caused by insulin resistance, lipotoxicity, and cardiovascular events. Current therapies for acromegaly are associated with suboptimal disease control.

MAR002是一种潜在的一流抗生长激素受体(GHR)抗体,正在为肢端肥大症开发。肢端肥大症是一种缩短寿命的疾病,其中许多发病率是由胰岛素抵抗,脂毒性和心血管事件引起的。目前治疗肢端肥大症的方法与疾病控制不佳有关。

It is estimated there are more than 30,000 patients with acromegaly in the U.S..

据估计,美国有30000多名肢端肥大症患者。。

Marea expects to initiate a Phase 1 clinical trial with MAR002 in the second half of 2025.

Marea预计在2025年下半年启动MAR002的1期临床试验。

Other Corporate Highlights

其他公司亮点

In June 2024, Marea announced $190 million in combined Series A and B financings.

2024年6月,Marea宣布了1.9亿美元的A系列和B系列融资。

Continued to build out senior leadership team; announced the appointments of Ian Clements, Ph.D., as chief financial officer, Rebecca Juliano, Ph.D., as chief development officer, and Max Zeiberg as senior vice president, corporate development.

继续建设高级领导团队;宣布任命Ian Clements博士为首席财务官,Rebecca Juliano博士为首席开发官,Max Zeiberg为公司开发高级副总裁。

Added Robert A. Harrington, M.D., to Board of Directors.

董事会增加了医学博士罗伯特·哈林顿(RobertA.Harrington)。

Presentation at the 43

在43

rd

rd公司

Annual J.P. Morgan Healthcare Conference

摩根大通医疗保健年度会议

Management will participate in the 43

管理层将参与43

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Annual J.P Morgan Healthcare Conference. In addition to hosting meetings, management will present an overview of the Company on Wednesday, January 15, at 11:30 a.m. PT in San Francisco.

摩根大通医疗保健年度会议。除了主持会议外,管理层还将于1月15日星期三上午11:30在旧金山PT介绍公司概况。

About Marea Therapeutics

关于Marea Therapeutics

Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardio-endocrine diseases. The company’s lead program, MAR001, is in Phase 2 clinical development for adults with metabolic dysfunction and high risk for cardiovascular disease.

Marea Therapeutics是一家临床阶段的生物技术公司,利用人类遗传学的最新进展开发一流的下一代心脏内分泌疾病药物。该公司的领先项目MAR001正在为代谢功能障碍和心血管疾病高风险的成年人进行第二阶段临床开发。

The company is also advancing MAR002 for the treatment of acromegaly. To learn more, please visit .

该公司还将于2002年3月推进肢端肥大症的治疗。要了解更多信息,请访问。

www.mareatx.com

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