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Lupus Therapeutics Statement on Phase 3 PHOENYCS GO Positive Data in Moderate-To-Severe Systemic Lupus

Lupus Therapeutics Statement on Phase 3 PHOENYCS GO Positive Data in Moderate-To-Severe Systemic Lupus

Lupus治疗声明:3期PHOENYCS GO研究对中重度全身性红斑狼疮的积极数据
PR Newswire ·  11:01

WASHINGTON, Nov. 19, 2024 /PRNewswire/ -- Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance (LRA), is encouraged by the positive Phase 3 PHOENYCS GO data reported by UCB and Biogen during ACR Convergence 2024. Study sponsors provided a detailed analysis of the pivotal trial to evaluate the efficacy and safety of dapirolizumab pegol (DZP) in patients with moderate-to-severe systemic lupus erythematosus (SLE).

华盛顿,2024年11月19日 / PRNewswire / -- 狼疮治疗,狼疮研究联盟的临床研究联盟 (LRA),对UCb和渤健公司在2024年ACR汇聚会议上报告的积极3期PHOENYCS GO数据感到鼓舞。研究赞助商提供了一项关键试验的详细分析,以评估达皮罗利祖单抗(DZP)在中重度系统性红斑狼疮(SLE)患者中的疗效和安全性。 根据研究赞助商的说法:“DZP实现了其主要终点,通过BICLA作为衡量疾病活动的终点,在所有器官系统上展示了统计学上和临床上显著的改善。与仅接受标准护理的参与者相比,接受DZP治疗的参与者在多个临床终点上观察到了更大的反应,包括疾病暴发减少50%。

Per the study sponsors: "DZP met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activity. A greater response was observed across multiple clinical endpoints among participants treated with DZP, including 50% less severe disease flares compared to participants on standard of care alone."

根据研究赞助商的说法:“DZP实现了其主要终点,通过BICLA作为衡量疾病活动的终点,在所有器官系统上展示了统计学上和临床上显著的改善。与仅接受标准护理的参与者相比,接受DZP治疗的参与者在多个临床终点上观察到了更大的反应,包括疾病暴发减少50%。

Following is a statement by Lupus Therapeutics Executive Vice President Stacie Bell, PhD:

以下是狼疮治疗执行副总裁Stacie Bell,博士的声明:

The Phase 3 PHOENYCS GO trial demonstrated significant improvement in SLE disease activity, making dapirolizumab pegol a promising candidate for treating moderate-to-severe SLE. By inhibiting the CD40 ligand, which plays a crucial role in the immune system response, dapirolizumab pegol offers a novel way to address multiple aspects of the underlying mechanisms of lupus and distinguishes the approach from currently available treatments.

PHOENYCS GO第3期试验显示了SLE疾病活动的显著改善,使得达皮罗利祖单抗成为治疗中度至重度SLE的有希望候选药物。通过抑制在免疫系统反应中扮演关键角色的CD40配体,达皮罗利祖单抗提供了一种新的方法来应对狼疮的潜在机制的多个方面,并将这种方法与当前可用的治疗方法区分开来。

Lupus Therapeutics is proud to have partnered with UCB and Biogen on this study, leveraging the organizational clinical expertise and LuCIN clinical site support. Most of all, Lupus Therapeutics is pleased that these promising outcomes may lead to another treatment option for those living with SLE.

Lupus Therapeutics很自豪能与UCb和渤健公司合作进行这项研究,借助组织临床专业知识和LuCIN临床现场支持。最重要的是,Lupus Therapeutics很高兴这些有希望的成果可能会为那些患有SLE的人提供另一种治疗选择。

Based on this trial, UCB and Biogen is initiating a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY, in 2024.

基于这项试验,UCb和渤健公司将于2024年启动第二阶段3试验,使用达匹罗单抗聚甲醛盐作为药物(PHOENYCS FLY)。

For more information, read the UCB-Biogen press release.

要了解更多信息,请阅读UCb-渤健公司的新闻稿。

SOURCE Lupus Research Alliance

资讯来源:Lupus Research Alliance

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