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MAR 001的IIa期试验积极数据在EAS大会上发布,用于治疗残留心血管风险。- Marea Therapeutics

Positive data from phase IIa trial of MAR 001 presented at EAS Congress for treating residual cardiovascular risk.- Marea Therapeutics

medthority 等信源发布 2025-05-09 11:00

可切换为仅中文


Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases,  presented positive data from a Phase IIa clinical trial of MAR 001 in a late-breaking oral session at the 93rd European Atherosclerosis Society (EAS) Congress being held May 4-7, 2025 in Glasgow, UK.

迈拉治疗公司(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首创的下一代心内分泌疾病药物,在2025年5月4日至7日于英国格拉斯哥举行的第93届欧洲动脉粥样硬化学会(EAS)大会上,于一场最新的口头报告环节中展示了MAR 001在IIa期临床试验中的积极数据。

MAR 001 is a first-in-class monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue..

MAR 001 是一种首创的单克隆抗体,靶向ANGPTL4,这是一种在脂肪组织中高度表达的蛋白质。

“We are very excited by these data from our Phase IIa study, which demonstrate the strong potential of MAR 001 to address the most important unaddressed lipid and metabolic drivers of atherosclerotic cardiovascular disease in high-risk patients,” said Josh Lehrer, M.D., M.Phil., FACC, chief executive officer of Marea.

“我们对这项 IIa 期研究的数据感到非常兴奋,这些数据展示了 MAR 001 在解决高危患者动脉粥样硬化性心血管疾病中最重要的未解决的脂质和代谢驱动因素方面的强大潜力,”Marea 首席执行官乔什·莱勒 (Josh Lehrer) 医学博士、哲学硕士、美国心脏病学会会员表示。

“We look forward to advancing MAR 001 into Phase IIb development for treating residual cardiovascular risk in patients who remain at highest risk despite aggressive standard of care therapies.”.

“我们期待将MAR 001推进到IIb期开发,用于治疗尽管接受了积极的标准治疗但仍处于最高风险的患者的残余心血管风险。”

“Atherosclerotic cardiovascular disease patients with elevated remnant cholesterol remain at an increased risk for major adverse cardiovascular events despite best available standard of care therapies,” said Ethan Weiss, M.D., chief scientific officer of Marea. “These data clearly validate the ability of MAR 001 to significantly lower remnant cholesterol and triglycerides by inhibiting ANGPTL4, supporting genetic findings and expected translation to substantial cardiovascular disease risk reduction.

“尽管接受了最佳的标准治疗,动脉粥样硬化性心血管疾病患者如果残余胆固醇水平升高,仍然面临较高的主要不良心血管事件风险,”Marea首席科学官Ethan Weiss博士表示。“这些数据明确验证了MAR 001通过抑制ANGPTL4显著降低残余胆固醇和甘油三酯的能力,支持了基因研究结果,并有望转化为大幅降低心血管疾病风险的效果。"

We believe MAR 001 has the potential to become an important new therapeutic option for patients.”.

我们相信MAR 001有潜力成为患者的重要新治疗选择。

Presentation Highlights:

演示亮点:

i. The primary objective of Marea’s randomized, double-blind, placebo-controlled Phase IIa clinical trial was to characterize the safety and tolerability of multiple doses of MAR 001 in participants with elevated triglycerides and remnant cholesterol.

Marea的随机、双盲、安慰剂对照的IIa期临床试验的主要目的是评估MAR 001在甘油三酯和残余胆固醇升高的人群中多次给药的安全性和耐受性。

ii. Secondary objectives were to describe the serum concentration of MAR 001 at selected timepoints and to characterize the effect of MAR 001 on triglyceride and remnant cholesterol metabolism following 12 weeks of treatment.

ii. 次要目标是描述在选定时间点MAR 001的血清浓度,并表征MAR 001在治疗12周后对甘油三酯和残余胆固醇代谢的影响。

iii. The study enrolled 55 participants with hypertriglyceridemia (fasting TGs ≥151 and ≤496 mg/dL) randomized to Q2W MAR 001 or placebo (blinded, 2:1 MAR 001:Placebo). Ten participants were randomized to the 150 mg MAR 001 arm, nine to the 300 mg MAR 001 arm, 17 to the 450 mg MAR 001 arm, and 19 to placebo..

iii. 该研究招募了55名高甘油三酯血症患者(空腹甘油三酯水平≥151且≤496 mg/dL),随机分配至每两周一次的MAR 001或安慰剂组(双盲,2:1 MAR 001:安慰剂)。其中10名参与者被随机分配至150 mg MAR 001组,9名至300 mg MAR 001组,17名至450 mg MAR 001组,19名至安慰剂组。

iv. MAR 001 demonstrated up to a 52.5% placebo-adjusted mean reduction in remnant cholesterol and up to a 52.7% placebo-adjusted mean reduction in triglycerides at 12 weeks.

iv. MAR 001 在 12 周时显示出残余胆固醇和甘油三酯分别高达 52.5% 和 52.7% 的安慰剂校正平均降幅。

v. In participants with significantly elevated triglyceride levels at baseline (≥200 mg/dL), MAR 001 demonstrated up to a 66.0% placebo-adjusted mean reduction in remnant cholesterol and up to a 64.0% placebo-adjusted mean reduction in triglycerides at Week 12.

在基线甘油三酯水平显著升高(≥200 mg/dL)的参与者中,MAR 001 在第 12 周时显示出残余胆固醇最多降低 66.0%(安慰剂校正平均值),甘油三酯最多降低 64.0%(安慰剂校正平均值)。

vii. MAR 001 was generally well tolerated, with no clinically significant findings, and no findings of elevated systemic inflammatory biomarkers or changes in mesenteric lymph node (MLN) size or local inflammation as assessed by MRI. There were no deaths or serious adverse events in any arm, and no adverse events with MAR 001 leading to study drug discontinuation..

vii. MAR 001 总体上耐受性良好,未发现有临床意义的结果,且通过MRI评估,未发现系统性炎症生物标志物升高或肠系膜淋巴结(MLN)大小改变或局部炎症。各组均无死亡或严重不良事件发生,亦无因 MAR 001 导致研究药物停用的不良事件。

Condition:

条件:

Remnant Cholesterol

残余胆固醇

Type:

类型:

drug

药物