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NEWTON, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that the first participant has been dosed in the open-label extension (OLE) portion of its Phase 2 ALTITUDE-AD clinical trial evaluating sabirnetug (ACU193) in people with early Alzheimer's disease..

马萨诸塞州牛顿市，2025年11月17日（环球新闻社）—— Acumen Pharmaceuticals, Inc.（纳斯达克股票代码：ABOS）是一家处于临床阶段的生物制药公司，致力于开发一种针对可溶性β淀粉样蛋白寡聚体（AβOs）的新型疗法用于治疗阿尔茨海默病（AD）。该公司今日宣布，在其评估sabirnetug（ACU193）针对早期阿尔茨海默病患者的二期ALTITUDE-AD临床试验的开放标签扩展（OLE）部分中，第一名参与者已接受给药。

The open-label extension provides all participants who completed the 18-month placebo-controlled portion of ALTITUDE-AD with the opportunity to receive sabirnetug at 35 mg/kg administered intravenously once every four weeks for an additional 52 weeks. Clinical measures and safety monitoring will be the same as in the placebo-controlled portion of the study..

开放标签扩展阶段为所有完成了 ALTITUDE-AD 研究中 18 个月安慰剂对照部分的参与者提供了机会，接受每四周一次、剂量为 35 mg/kg 的 sabirnetug 静脉注射，持续额外 52 周。临床指标和安全性监测将与研究的安慰剂对照部分相同。

'Initiating the open-label extension study represents our ongoing commitment to the participants who have contributed in ALTITUDE-AD and provides us with valuable long-term safety and efficacy data,' said Eric Siemers, M.D., Chief Medical Officer of Acumen Pharmaceuticals. 'We expect the results of this study to supplement the broader data package supporting sabirnetug, and we look forward to gathering additional insights that will support our continued development of this potentially differentiated therapeutic approach.'.

“启动开放标签扩展研究代表了我们对参与ALTITUDE-AD研究的受试者的持续承诺，同时也为我们提供了宝贵的安全性和有效性长期数据，” Acumen制药公司首席医疗官Eric Siemers博士说道。“我们预计这项研究的结果将补充支持sabirnetug的更广泛数据包，我们期待收集更多见解，以支持我们继续开发这种潜在差异化的治疗方法。”

Sabirnetug is the first humanized monoclonal antibody to demonstrate in AD patients selective target engagement of AβOs, a soluble and highly synaptotoxic form of amyloid-beta (Aβ) that accumulates early in AD and is a persistent trigger of synaptic dysfunction and neurodegeneration. In the Phase 1 INTERCEPT-AD trial, sabirnetug demonstrated a favorable safety profile with low overall rates of ARIA-E, evidence of target engagement, and positive effects on fluid and imaging biomarkers including reduction in amyloid plaques in the two groups of participants given the highest doses..

Sabirnetug 是首个在阿尔茨海默病（AD）患者中展示出对可溶性、高度突触毒性的β-淀粉样蛋白（Aβ）寡聚体（AβOs）具有选择性靶向作用的人源化单克隆抗体。AβOs 在阿尔茨海默病早期积累，是导致突触功能障碍和神经退行性变的持续诱因。在一期临床试验 INTERCEPT-AD 中，Sabirnetug 显示出良好的安全性，ARIA-E 的总体发生率较低，并显示出靶点结合的证据，同时对液体和影像学生物标志物产生积极影响，包括在接受最高剂量的两组参与者中减少淀粉样蛋白斑块。

Acumen expects to report topline results from ALTITUDE-AD in late 2026.

Acumen预计将在2026年底报告ALTITUDE-AD的初步结果。

About Sabirnetug (ACU193)

关于Sabirnetug（ACU193）

Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration.

Sabirnetug（ACU193）是一种人源化单克隆抗体（mAb），因其对可溶性β淀粉样蛋白寡聚体（AβOs）具有选择性而被发现和开发，AβOs是相对于Aβ单体和淀粉样斑块而言毒性极强且致病的Aβ形式。可溶性AβOs已被观察到是强效的神经毒素，能够与神经元结合，抑制突触功能并诱导神经退行性病变。

By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S.

通过选择性靶向有毒的可溶性Aβ寡聚体（AβOs），sabirnetug旨在验证可溶性Aβ寡聚体是阿尔茨海默病（AD）神经退行过程的早期且持续的根本原因这一假设。Sabirnetug已获得美国食品药品监督管理局（FDA）授予的快速通道资格，用于治疗早期AD。

Food and Drug Administration and is currently being evaluated in a Phase 2 study in people with early AD.  .

食品和药物管理局目前正在早期阿尔茨海默病患者中进行第二阶段的研究评估。

About ALTITUDE-AD (Phase 2)

关于ALTITUDE-AD（第2阶段）

Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.

2024年启动的ALTITUDE-AD是一项二期、多中心、随机、双盲、安慰剂对照的临床试验，旨在评估每四周一次静脉注射sabirnetug（ACU193）在减缓早期阿尔茨海默病患者认知和功能衰退方面的有效性和安全性，与安慰剂进行对比。

The study has enrolled 542 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD) at multiple investigative sites located in the United States, Canada, the European Union and the United Kingdom. More information can be found on .

该研究在美国、加拿大、欧盟和英国的多个研究地点招募了542名早期阿尔茨海默病（轻度认知障碍或因阿尔茨海默病导致的轻度痴呆）患者。更多信息可以在此处找到。

www.clinicaltrials.gov

www.clinicaltrials.gov

, NCT identifier NCT06335173.

，NCT标识符NCT06335173。

About Acumen Pharmaceuticals, Inc.

关于Acumen Pharmaceuticals公司

Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology.

Acumen制药是一家临床阶段的生物制药公司，正在开发一种新型疗法，靶向有毒的可溶性β淀粉样蛋白寡聚体（AβOs），用于治疗阿尔茨海默病（AD）。Acumen的科学创始人开创了AβOs的研究，越来越多的证据表明，AβOs是阿尔茨海默病病理学的早期和持续触发因素。

Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in people with early Alzheimer’s disease, following positive results in its Phase 1 trial INTERCEPT-AD.

Acumen 目前正专注于在其正在进行的第二阶段临床试验 ALTITUDE-AD（NCT06335173）中推进其研究性候选产品 sabirnetug（ACU193），这是一种选择性靶向有毒可溶性 AβOs 的人源化单克隆抗体，试验对象为早期阿尔茨海默病患者。此前，该药物在第一阶段试验 INTERCEPT-AD 中取得了积极结果。

Acumen is also investigating a subcutaneous formulation of sabirnetug using Halozyme’s proprietary ENHANZE.

Acumen还在使用Halozyme的专有ENHANZE技术研究sabirnetug的皮下注射制剂。

®

®

drug delivery technology. Acumen is also collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery (EBD™) therapy for Alzheimer’s disease utilizing a transferrin-receptor-targeting blood-brain barrier-penetrating technology. The company is headquartered in Newton, Mass. For more information, visit .

药物递送技术。Acumen 还与 JCR 制药公司合作，利用一种靶向转铁蛋白受体的血脑屏障穿透技术，开发用于阿尔茨海默病的增强脑部递送（EBD™）疗法。该公司总部位于马萨诸塞州牛顿市。欲了解更多信息，请访问 。

www.acumenpharm.com

www.acumenpharm.com

..

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Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.  Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” “milestone” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

本新闻稿包含《1995年私人证券诉讼改革法案》所指的前瞻性陈述。任何描述Acumen的目标、预期、财务或其他预测、意图或信念的陈述均为前瞻性陈述，应被视为具有风险的陈述。诸如“相信”、“预期”、“预计”、“可能”、“应该”、“将”、“寻求”、“旨在”、“计划”、“潜力”、“里程碑”等词语以及类似表达旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Forward-looking statements include statements concerning the therapeutic potential of Acumen’s product candidate, sabirnetug (ACU193), including against other antibodies. These statements are based upon the current beliefs and expectations of Acumen management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics.

前瞻性声明包括有关Acumen产品候选物sabirnetug（ACU193）治疗潜力的声明，包括与其他抗体的对比。这些声明基于Acumen管理层当前的信念和期望，并受某些因素、风险和不确定性的约束，特别是那些在发现、开发和商业化安全有效的人类治疗药物过程中固有的风险。

Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC.

此类风险可能会因地缘政治事件和宏观经济状况的影响而放大，例如通胀上升、利率提高、供应中断以及信贷和金融市场的不确定性。有关 Acumen 计划的这些及其他风险的更多信息，已在 Acumen 向证券交易委员会（“SEC”）提交的文件中详细说明，包括 Acumen 最近的年度报告 Form 10-K，以及随后向 SEC 提交的文件中。

Copies of these and other documents are available from Acumen.  Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly d.

这些文件的副本及其他文件可从Acumen获取。更多相关信息将会在Acumen不时向美国证券交易委员会提交的其他文件中提供。这些前瞻性声明仅截至本文发布之日有效，Acumen明确表示...

Investors:

投资者：

Alex Braun

亚历克斯·布劳恩

abraun@acumenpharm.com

abraun@acumenpharm.com

Media:

媒体：

Jon Yu

于荣

ICR Healthcare

ICR医疗保健

AcumenPR@icrhealthcare.com

AcumenPR@icrhealthcare.com