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75% of patients in the rivaroxaban arm voluntarily switched from the once-daily oral anticoagulant to once-monthly abelacimab Landmark AZALEA-TIMI 71 Study previously stopped early due to an overwhelming benefit favoring abelacimab relative to rivaroxaban across all bleeding endpoints Data Monitoring Committee (DMC) recommended an open-label extension for all eligible patients to benefit from abelacimab treatment Abelacimab is a once-monthly, highly selective, fully human monoclonal antibody that achieves a near complete 99% inhibition of Factor XI CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Anthos Therapeutics, Inc., a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today provided an update on the transition of patients in the open-label extension (OLE) portion of the AZALEA-TIMI 71 study.
利伐沙班组75%的患者自愿从每日一次的口服抗凝剂改为每月一次的abelacimab里程碑式的AZALEA-TIMI 71研究,由于在所有出血终点数据监测委员会(DMC)中相对于利伐沙班而言,abelacimab具有压倒性的优势,因此提前停止了这项研究。数据监测委员会(DMC)建议对所有符合条件的患者进行开放标签扩展,以从abelacimab治疗中受益abelacimab是一种每月一次的高选择性全人单克隆抗体,可实现对因子XI的几乎完全99%的抑制作用。剑桥,马萨诸塞州,2024年6月6日(环球通讯社)——Anthos Therapeutics,Inc.,一家临床阶段公司,由布莱克创立,开发心血管疾病的创新疗法Stone Life Sciences(BXLS)今天提供了AZALEA-TIMI 71研究开放标签扩展(OLE)部分患者过渡的最新信息。
When the independent data monitoring committee (DMC) recommended that the study be stopped early because of the substantially greater than anticipated reduction in bleeding events favoring abelacimab over rivaroxaban, they also recommended that an optional open-label extension be made available so that all eligible patients could potentially benefit from abelacimab treatment.
当独立数据监测委员会(DMC)建议尽早停止研究时,因为有利于阿贝拉西单抗而非利伐沙班的出血事件的减少明显大于预期,他们还建议提供可选的开放标签延长,以便所有符合条件的患者都可能从阿贝拉西单抗治疗中受益。
“The impressive bleeding reductions with abelacimab in the AZALEA-TIMI 71 study represent a potential game changer for how we treat patients with atrial fibrillation in the future, so it was no surprise when almost 84% of eligible patients, including the vast majority who had been on rivaroxaban during the trial, voluntarily decided to enter the open-label extension to receive abelacimab,” said Dr.
“在AZALEA-TIMI 71研究中,abelacimab令人印象深刻的出血减少代表了我们未来如何治疗房颤患者的潜在游戏规则改变者,因此当近84%的符合条件的患者(包括绝大多数在试验期间服用利伐沙班的患者)自愿决定进入开放标签延期以接受abelacimab时,也就不足为奇了,”Dr。
Christian T. Ruff, MD, MPH, Principal Investigator of AZALEA-TIMI 71, the Director of General Cardiology at Brigham and Women's.
Christian T.Ruff,医学博士,公共卫生硕士,AZALEA-TIMI 71的首席研究员,Brigham and Women's的总心脏病学主任。