Schlieren-based startup, Neurimmune, which develops drug candidates for central nervous system (CNS) and related protein aggregation diseases, has, in collaboration with its partner Alexion, advanced its drug candidate ALXN2220 into phase 3. This marks a significant step in the company’s journey to addressing the serious clinical condition ATTR-CM.  .

基于纹影技术的初创公司Neurimmune开发了中枢神经系统（CNS）和相关蛋白质聚集疾病的候选药物，并与其合作伙伴Alexion合作，将其候选药物ALXN2220推进了第三阶段。这标志着该公司在解决ATTR-CM严重临床症状的过程中迈出了重要的一步。

Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, systemic clinical condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis. Despite recent advances in slowing disease progression, there is currently no treatment available to deplete cardiac ATTR amyloid and revert cardiac dysfunction. Schlieren-based startup, Neurimmune, which develops drug candidates for central nervous system (CNS) and related protein aggregation diseases including Alzheimer’s disease, amyotrophic lateral sclerosis, frontotemporal dementia and ATTR cardiomyopathy, is currently testing a drug candidate, ALXN2220 (formerly NI006), a human antibody targeting ATTR Cardiomyopathy.  .

运甲状腺素蛋白介导的淀粉样心肌病（ATTR-CM）是一种诊断不足的全身性临床疾病，可在诊断后四年内导致进行性心力衰竭和高死亡率。尽管最近在减缓疾病进展方面取得了进展，但目前尚无可用于消耗心脏ATTR淀粉样蛋白并恢复心脏功能障碍的治疗方法。基于纹影技术的初创公司Neurimmune目前正在测试一种候选药物ALXN2220（以前称为NI006），一种针对ATTR心肌病的人类抗体，该公司开发中枢神经系统（CNS）和相关蛋白质聚集疾病（包括阿尔茨海默氏病，肌萎缩侧索硬化症，额颞叶痴呆和ATTR心肌病）的候选药物。。

In 2022, Neurimmune entered into an exclusive global collaboration and license agreement with Alexion, AstraZeneca’s Rare Disease group, for ALXN2220. Neurimmune is responsible for completion of the phase 1b clinical study on behalf of Alexion, with Alexion incurring certain trial costs. Aside from the phase 1b trial, Alexion is responsible for further clinical development, manufacturing, and commercialization as ALXN2220. The two companies have now initiated the phase 3 of the DepleTTR-CM clinical study to assess the efficacy and safety of ALXN2220 for the treatment of ATTR-CM. .

2022年，Neurimmune与阿斯利康罕见病集团Alexion就ALXN2220达成了独家全球合作和许可协议。Neurimmune负责代表亚力兄完成1b期临床研究，亚力兄承担一定的试验费用。除了1b期试验外，亚力兄还负责作为ALXN2220进行进一步的临床开发，制造和商业化。两家公司现已启动DepleTTR CM临床研究的第3阶段，以评估ALXN2220治疗ATTR-CM的疗效和安全性。

The DepleTTR-CM clinical study was started in early 2020. It is a randomized, double-blind, international multicenter clinical study to evaluate the efficacy and safety of ALXN2220 for the treatment of ATTR-CM. Participants will receive either ALXN2220 or placebo via intravenous infusion every four weeks.

DREATTR CM临床研究于2020年初开始。这是一项随机，双盲，国际多中心临床研究，旨在评估ALXN2220治疗ATTR-CM的有效性和安全性。参与者将每四周通过静脉输注接受ALXN2220或安慰剂。

The primary endpoint is a composite endpoint to assess both survival and cardiovascular health over the treatment period of up to 48 months. .

主要终点是一个综合终点，用于评估长达48个月的治疗期间的生存和心血管健康。。

Roger M. Nitsch, President and CEO of Neurimmune, is very excited about this development and states, “The DepleTTR-CM study is the first study designed to demonstrate that depletion of cardiac amyloid can lead to improved cardiovascular health in patients with ATTR-CM. The initiation of Phase 3 is an important milestone.

Neurimmune总裁兼首席执行官罗杰·尼奇（Roger M.Nitsch）对这一发展感到非常兴奋，并表示：“DEPARTTR CM研究是第一项旨在证明心脏淀粉样蛋白耗竭可改善ATTR-CM患者心血管健康的研究。第三阶段的启动是一个重要的里程碑。

We thank the Alexion team, the clinical investigators and the study participants for their contributions and commitment to this program.”  (Press release / SR / RAN) .

我们感谢亚力兄团队、临床研究人员和研究参与者对该项目的贡献和承诺。”（新闻稿/SR/RAN）。

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