Sanofi's neurology pipeline has had a hole blown in it after a phase 3 trial of riliprubart (SAR445088) in rare disease chronic inflammatory demyelinating polyneuropathy (CIDP) was stopped for futility.

赛诺菲的神经学产品管线遭受重创，因其罕见病慢性炎性脱髓鞘性多发性神经病（CIDP）三期临床试验中利普利鲁单抗（SAR445088）因无效而终止。

The MOBILIZE trial will be stopped early and abandoned after an interim analysis by the study's independent data monitoring committee found the C1s-targeting antibody 'is unlikely to provide sufficient efficacy.'

MOBILIZE 试验将在中期分析后被提前终止并放弃，因为该研究的独立数据监查委员会发现，靶向 C1s 的抗体“不太可能提供足够的疗效”。

CIDP is a rare autoimmune disease of the peripheral nervous system that causes fatigue, muscle weakness, and loss of feeling that can lead to serious disability and the need to use a wheelchair. There are approved treatments, including Argenx's FcRn inhibitor

慢性炎性脱髓鞘性多发性神经病（CIDP）是一种罕见的周围神经系统自身免疫性疾病，会导致疲劳、肌肉无力和感觉丧失，可能引发严重残疾并需要依靠轮椅。目前已有获批的治疗方法，包括 Argenx 公司的 FcRn 抑制剂。

Vyvgart Hytrulo

Vyvgart Hytrulo

and Takeda's intravenous immune globulin (IVIg) product HyQvia, but options are limited.

以及武田的静脉注射免疫球蛋白（IVIg）产品HyQvia，但选择有限。

MOBILIZE started in 20924 and recruited approximately 140 people with CIDP who were not responding to current treatment, which also includes corticosteroids, and was comparing intravenous and subcutaneous formulations of riliprubart to matched placebos over 24 weeks, followed by riliprubart for another 24 weeks, and with around two years of overall follow-up..

MOBILIZE 研究于 20924 年启动，招募了约 140 名对当前治疗（包括皮质类固醇）无反应的慢性炎性脱髓鞘性多发性神经病（CIDP）患者，在 24 周内比较静脉注射和皮下注射制剂的 riliprubart 与匹配安慰剂的疗效，随后再使用 riliprubart 治疗 24 周，总体随访时间约为两年。

Sanofi has another shot on goal for riliprubart in CIDP in the phase 3 VITALIZE trial, which is comparing the drug to IVIg in adults with CIDP who were on maintenance treatment with IVIg at enrolment. That also started in 2024, with a readout due next year, but like MOBILIZE, it will be assessed for interim signals by the data monitoring committee..

赛诺菲在慢性炎性脱髓鞘性多发性神经病（CIDP）领域为riliprubart再次发起冲击，开展III期VITALIZE试验，该试验正在将riliprubart与静脉注射免疫球蛋白（IVIg）进行比较，受试者为入组时正接受IVIg维持治疗的成年CIDP患者。该试验也于2024年启动，预计明年公布结果，但与MOBILIZE试验一样，数据监查委员会将对其期中信号进行评估。

Sanofi's pipeline listing for the drug also shows a phase 2 study is ongoing for antibody-mediated rejection in transplant patients. It was previously tested for another autoimmune condition – cold agglutinin disease – but that does not seem to be an active programme any more.

赛诺菲的药物研发管线列表显示，针对移植患者抗体介导排斥反应的二期临床试验正在进行中。该药此前曾针对另一种自身免疫性疾病——冷凝集素病——进行过测试，但该项目似乎已不再活跃。

In 2022, Sanofi won FDA approval for an anti-C1s antibody,

2022年，赛诺菲获得了美国食品药品监督管理局（FDA）对一种抗C1s抗体的批准。

Enjaymo

恩杰莫

(sutimlimab), which became the first therapy in the US for CAD, but the company is not currently running clinical trials in any follow-up indications, suggesting its focus on C1s has shifted to riliprubart.

（sutimlimab）成为美国首个用于冷凝集素病（CAD）的治疗药物，但该公司目前并未在任何后续适应症中开展临床试验，这表明其对C1s的关注已转向riliprubart。

Both drugs are derived from Sanofi's investment in Biogen spinoff

这两款药物均源自赛诺菲对渤健分拆公司的投资

Bioverativ

Bioverativ

, a company it acquired for $11.6 billion in 2018.

，该公司于2018年以116亿美元收购了这家公司。

C1s is an enzyme, part of the classical complement pathway, and is thought to dampen down various inflammatory processes orchestrated by the innate immune system. It is being targeted by various other drug developers, including Dianthius Therapeutics, which is running clinical trials of its claseprubart (DNTH103) candidate in autoimmune diseases like multifocal motor neuropathy (MMN) and generalised myasthenia gravis (gMG)..

C1s是一种酶，属于经典补体通路的一部分，被认为能够抑制由先天免疫系统介导的各种炎症过程。包括Dianthius Therapeutics在内的多家药物开发商正将其作为靶点；Dianthius Therapeutics正在对其候选药物claseprubart（DNTH103）开展临床试验，用于治疗多灶性运动神经病（MMN）和全身型重症肌无力（gMG）等自身免疫性疾病。