NEW YORK, May 29, 2024 /PRNewswire/ -- Remedy Pharmaceuticals, Inc., a pioneer in stroke drug development, announced that prespecified subgroup analyses from the Phase 3 CHARM clinical trial of CIRARA (IV glibenclamide) showed meaningful improvements in functional outcomes on the modified Rankin Scale (mRS), which were further validated in post hoc analyses..

2024年5月29日，纽约/PRNewswire/--中风药物开发的先驱Remedy Pharmaceuticals，Inc.宣布，来自CIRARA（IV格列本脲）3期CHARM临床试验的预先指定的亚组分析显示，改良Rankin量表（mRS）的功能结果有显着改善，这在事后分析中得到了进一步验证。。

The findings follow the early termination of the pivotal Phase 3 trial by Cambridge-based Biogen after a strategic realignment of resources, and the return of the program to Remedy.

在对资源进行战略性调整后，总部位于剑桥的Biogen提前终止了关键的3期试验，并恢复了该计划的补救措施。

The CHARM clinical trial was a multicenter, multinational, double-blind, randomized, placebo-controlled Phase 3 study involving patients aged 18-85 with a large hemispheric infarction (LHI), as indicated by an Alberta Stroke Program Early Computed Tomographic (CT) Score (ASPECTS) value of 1-5 (on a scale of 0-10) or an ischemic core volume of 80-300 ml by CT perfusion (CTP) or magnetic resonance imaging (MRI) diffusion weighted imaging.

CHARM临床试验是一项多中心，多国，双盲，随机，安慰剂对照的3期研究，涉及18-85岁患有大半球梗塞（LHI）的患者，如阿尔伯塔省卒中计划早期计算机断层扫描（CT）所示。通过CT灌注（CTP）或磁共振成像（MRI）扩散加权成像，评分（ASPECTS）值为1-5（0-10分）或缺血核心体积为80-300毫升。

Patients were eligible if study drug was expected to start within 10 hours after they were last known well and were randomly assigned in a 1:1 ratio of CIRARA or placebo. A total of 535 patients were enrolled, including 431 patients aged 18-70 (the efficacy analysis population) and 81 patients aged 71-85..

如果研究药物预计在最后一次被熟知后10小时内开始，并且以1:1的比例随机分配CIRARA或安慰剂，则患者符合条件。共纳入535名患者，其中431名年龄在18-70岁（疗效分析人群）和81名年龄在71-85岁的患者。。

Despite neutral top-line results, in pre-specified analyses, patients who received rtPA, underwent endovascular thrombectomy (EVT), were enrolled using CTP/MRI, had wake-up strokes, or were enrolled in the U.S., all had directionally improved functional outcomes in favor of CIRARA. A pre-specified analysis in patients with an NIH Stroke Scale (NIHSS) ≤20 (n=274) yielded statistically significant improvements in functional outcomes (Odds Ratio 1.66, p=0.03).

尽管有中性的顶线结果，但在预先指定的分析中，接受rtPA，接受血管内血栓切除术（EVT），使用CTP/MRI入组，患有唤醒性中风或在美国入组的患者，均具有定向改善的功能结果，有利于CIRARA。对NIH卒中量表（NIHSS）≤20（n=274）的患者进行预先指定的分析，结果显示功能结果有统计学意义的改善（优势比1.66，p=0.03）。

With EVT therapy increasingly used in LHI, the Odds Ratio of 1.75 in the EVT subset, while not statistically significant, was particularly encouraging..

随着EVT疗法越来越多地用于LHI，EVT子集中1.75的优势比虽然没有统计学意义，但特别令人鼓舞。。

Building on these findings, post hoc analyses examining the impact of stroke severity on outcomes were performed and revealed significant findings:

在这些发现的基础上，进行了事后分析，检查了中风严重程度对结局的影响，并揭示了重要发现：

In the mITT population with CTP/MRI lesion volume <125mL (n=118), the Odds Ratio = 2.15 in favor of CIRARA (p=0.04). Mortality was numerically decreased from 22% in the placebo to 14% in the CIRARA group without an increase in severe disability. The proportion of patients with a mRS 0-3 was 36% for the CIRARA group vs.

在CTP/MRI病变体积小于125mL的mITT人群中（n=118），优势比=2.15有利于CIRARA（p=0.04）。死亡率从安慰剂组的22%下降到CIRARA组的14%，而严重残疾没有增加。CIRARA组mRS 0-3的患者比例为36%。

19% for placebo, an 89% increase..

安慰剂组为19%，增加了89%。。

In the mITT EVT population with CTP/MRI lesion volume <125mL (n=34), the Odds Ratio = 7.13 in favor of CIRARA (p=0.01). Mortality was numerically decreased from 31% in the placebo to 6% in the CIRARA group without an increase in severe disability. The proportion of patients with mRS 0-3 was 62% for the CIRARA group vs.

在CTP/MRI病变体积小于125mL的mITT EVT人群中（n=34），优势比=7.13有利于CIRARA（p=0.01）。死亡率从安慰剂组的31%下降到CIRARA组的6%，而严重残疾没有增加。CIRARA组mRS 0-3患者的比例为62%。

31% for placebo, a 100% increase..

安慰剂组为31%，增加了100%。。

Dr. W. Taylor Kimberly, MD, PhD., Chief, Division of Neurocritical Care at Massachusetts General Hospital, Associate Professor of Neurology at Harvard Medical School and co-principal investigator on the CHARM study, commented, 'These findings are very promising and suggest that CIRARA is complementary to current standard of care, such as tPA and endovascular therapy, and could be the next big advancement in the treatment of large hemispheric infarctions.'.

W.Taylor Kimberly博士，医学博士。，马萨诸塞州总医院神经重症监护科科长、哈佛医学院神经病学副教授兼CHARM研究联合首席研究员评论道，“这些发现非常有希望，表明CIRARA是对目前护理标准的补充，如tPA和血管内治疗，可能是治疗大半球梗塞的下一个重大进展。”。

'Mortality and long-term disability remain stubbornly high, especially in cases of severe stroke,' notes Kevin Sheth, MD, Professor of Neurology and Neurosurgery and a Director of the Yale Center for Brain & Mind Health, and co-principal investigator on the CHARM study. 'CIRARA could help the tens of thousands of patients who fall victim to LHI each year have a fighting chance to live and enjoy productive lives.'.

“死亡率和长期残疾率仍然居高不下，特别是在严重中风的情况下，”神经病学和神经外科教授、耶鲁大学大脑与心理健康中心主任、CHARM研究联合首席研究员凯文·谢思（KevinSheth）指出CIRARA可以帮助每年成千上万的LHI受害者获得生存和享受富有成效生活的战斗机会。”。

'Advancing medicine cannot happen without the truly inspiring dedication of participants, their families, and the clinical investigators around the world,' said Sven Jacobson CEO of Remedy. 'We thank Biogen for investing over $200 million in this program, and express our gratitude to all the people involved in the CHARM study who have brought us that much closer to achieving our goal of advancing medicine for those in desperate need.'.

Remedy首席执行官斯文·雅各布森（Sven Jacobson）说：“如果没有参与者、他们的家人和世界各地的临床研究人员真正鼓舞人心的奉献精神，就不可能推进医学的发展。”我们感谢Biogen为这个项目投资了2亿多美元，并感谢所有参与CHARM研究的人，他们使我们离实现为急需者推进医学的目标更近了一步。”。

Data from the CHARM study was presented at the 10th European Stroke Organization Conference, May 15-17 in Basel, Switzerland.

CHARM研究的数据于5月15日至17日在瑞士巴塞尔举行的第十届欧洲卒中组织会议上公布。

ABOUT REMEDY

关于补救措施

New York-based Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on developing and bringing lifesaving treatments to people affected by acute central nervous system (CNS) disease and injuries. The company is planning a confirmatory Phase 3 study of CIRARA in LHI..

总部位于纽约的Remedy Pharmaceuticals，Inc.是一家私营临床阶段制药公司，专注于为受急性中枢神经系统（CNS）疾病和伤害影响的人开发和提供救生治疗。该公司正在计划对LHI的CIRARA进行第三阶段验证性研究。。

Contact:

联系人：

Sven Jacobson

斯文·雅各布森

CEO

首席执行官

Remedy Pharmaceuticals

补救药物

212.586.2226

212.586.2226

sven@remedypharmaceuticals.com

sven@remedypharmaceuticals.com

www.remedypharmaceuticals.com

www.remedypharmaceuticals.com

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