Brussels, Belgium – 22 October 2024 – 7.00AM CEST – UCB today announced that the results of its double-blind TOGETHER (AH0003) Phase 2a study of bepranemab - an investigational anti-tau antibody - in people living with prodromal to mild Alzheimer’s Disease (AD), have been accepted for presentation in a late-breaking symposium at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting.2 The CTAD meeting will take place in Madrid, Spain, October 29 – November 1, 2024..

比利时布鲁塞尔–2024年10月22日–CEST上午7:00–UCB今天宣布，其对患有前驱至轻度阿尔茨海默氏病（AD）的人群进行的贝普拉尼单抗（一种研究性抗tau抗体）的双盲联合（AH0003）2a期研究结果已被接受在2024年阿尔茨海默氏病临床试验（CTAD）会议的最新研讨会上发表。2 CTAD会议将于2024年10月29日至11月1日在西班牙马德里举行。。

The presentation will highlight primary and key secondary results from the Phase 2a study, including clinical, safety, and imaging endpoints. This acceptance underscores UCB’s commitment to addressing the urgent need for new treatment options for Alzheimer's disease.

演讲将重点介绍 2a 期研究的主要结果和关键次要结果，包括临床、安全性和成像终点。这项研究的通过彰显了 UCB 致力于满足阿尔茨海默病对新治疗方案的迫切需求。

“We are pleased to have our innovative research program recognized by the CTAD committee and look forward to sharing the encouraging results of the TOGETHER study with the scientific community. These new data represent an important step in building a rigorous body of evidence evaluating bepranemab as an investigational treatment option, for people living with early Alzheimer’s disease,” said Alistair Henry, Chief Scientific Officer, UCB..

“我们很高兴我们的创新研究计划得到CTAD委员会的认可，并期待着与科学界分享共同研究的令人鼓舞的结果。这些新数据代表了建立一个严格的证据体系的重要一步，该证据体系评估贝普拉尼单抗作为早期阿尔茨海默氏病患者的研究性治疗选择，”加州大学伯克利分校首席科学官阿利斯泰尔·亨利说。。

TOGETHER is a Phase 2a, global, multicenter, participant- and investigator-blind, placebo-controlled, parallel-group study designed to investigate the efficacy, safety and tolerability of bepranemab (two dose levels) – administered intravenously every 4 weeks – versus placebo in participants with prodromal (40% of study population) or mild (60% of study population) Alzheimer’s disease over an 80-week treatment period, followed by a 48-week open-label extension period, and a 16-week safety follow-up period.1.

这是一项2a期、全球、多中心、参与者和研究者盲法、安慰剂对照、平行组研究，旨在研究贝普雷单抗（两种剂量水平）的疗效、安全性和耐受性（每4周静脉注射一次）与安慰剂相比，在80周的治疗期内，前驱（40%的研究人群）或轻度（60%的研究人群）阿尔茨海默病患者的疗效、安全性和耐受性，随后是48周的开放标签延长期和16周的安全随访期。

Details of the late-breaking symposium:

最新召开的研讨会详情：

Title: Results from TOGETHER, a double-blind, placebo-controlled Phase 2 study evaluating efficacy, safety and tolerability of bepranemab in prodromal–mild Alzheimer’s disease

标题：一项双盲、安慰剂对照的2期研究的结果，该研究评估了贝普雷单抗在前驱轻度阿尔茨海默病中的疗效、安全性和耐受性

Presenters: Martin Citron, PhD (UCB Pharma); Matthew E Barton, PhD (UCB Pharma); Randall J Bateman, MD (Washington University School of Medicine, St Louis, MO, USA)

主持人：Martin Citron博士（UCB Pharma）；Matthew E Barton博士（UCB Pharma）；Randall J Bateman，医学博士（华盛顿大学医学院，美国密苏里州圣路易斯）

Date/Time: October 31, 5:10pm CET

日期/时间：欧洲中部时间10月31日下午5:10

The CTAD meeting is one of the leading forums for the latest developments in clinical trials for Alzheimer’s disease and other dementias. Attendees include experts from across the pharmaceutical, biotechnology, and medical communities who share a common goal of advancing treatment for Alzheimer’s disease..

CTAD会议是阿尔茨海默病和其他痴呆症临床试验最新进展的主要论坛之一。与会者包括来自制药、生物技术和医学界的专家，他们有共同的目标，即推进阿尔茨海默氏病的治疗。。

UCB also announced today that the company has regained all global rights to bepranemab following termination of a Collaboration Agreement with Genentech, a member of the Roche Group, and Roche. In July 2020, UCB entered a worldwide, exclusive license agreement with Roche and Genentech, for the global development, manufacturing, and commercialization of bepranemab in Alzheimer’s disease.3.

UCB今天还宣布，在与罗氏集团成员基因泰克（Genentech）和罗氏（Roche）的合作协议终止后，该公司已重新获得贝普拉尼单抗的所有全球权利。2020年7月，UCB与罗氏（Roche）和基因泰克（Genentech）签订了全球独家许可协议，用于阿尔茨海默病（Alzheimer's disease）中贝普雷单抗的全球开发，制造和商业化。

For more information, visit https://www.ucb.com/clinical-studies/Clinical-Trials?studyId=AH0003 or for the official CTAD program visit PROGRAM_CTAD2024_WEB October 14.pdf (ctad-alzheimer.com).

有关更多信息，请访问https://www.ucb.com/clinical-studies/Clinical-Trials?studyId=AH0003或访问CTAD官方计划访问program\u CTAD2024\u WEB October 14.pdf（CTAD alzheimer.com）。

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

本版本讨论了药物在开发中的研究用途，并不打算传达有关疗效或安全性的结论。不能保证此类产品的任何研究用途将成功完成临床开发或获得卫生当局的批准。

About bepranemab

空虚关于贝普拉内马尔

Bepranemab is a recombinant, humanised, full-length immunoglobulin G4 monoclonal antibody (mAb) that specifically targets human tau protein.4,5 Bepranemab targets a central region of tau (amino acids 235–250), near to the microtubule binding region (MTBR). 4,6 The rationale of this approach is that a mid-region antibody will more potently interfere with cell-to-cell propagation of pathogenic, aggregated tau than antibodies that target other regions of tau (ie., the N-terminus).4,6,7.

Bepranemab是一种重组，人源化的全长免疫球蛋白G4单克隆抗体（mAb），可特异性靶向人tau蛋白。4,5 Bepranemab靶向tau的中心区域（氨基酸235-250），靠近微管结合区（MTBR）。4,6这种方法的基本原理是，与靶向tau其他区域（即N端）的抗体相比，中间区域抗体将更有效地干扰致病性聚集tau的细胞间传播[4,6,7]。

About UCB

关于UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023.

比利时布鲁塞尔UCB（www.UCB.com）是一家全球生物制药公司，专注于发现和开发创新药物和解决方案，以改变患有严重免疫系统或中枢神经系统疾病的人的生活。该公司在大约40个国家拥有约9000名员工，2023年实现收入53亿欧元。