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Cumulus Neuroscience与 Transpharmation合作,将客观脑电图测量从临床前研究推进至首次人体试验

Cumulus Neuroscience and Transpharmation Partner to Carry Objective EEG Measurement from Preclinical Research into First-in-Human Studies

CISION 等信源发布 2026-10-14 16:00

可切换为仅中文


The two companies will work jointly with biopharma sponsors to provide a bridge between pre-clinical work and first-in-human studies, aligning quantitative EEG and cognitive endpoints across species so that a single objective measure of brain function follows a molecule from animal models into first-in-human trials.

这两家公司将与生物制药申办方携手合作,在临床前工作与首次人体研究之间搭建桥梁,跨物种对齐定量脑电图(qEEG)和认知终点指标,从而使一项单一的客观脑功能评估指标能够贯穿从动物模型到首次人体试验的整个分子研发过程。

A cross-species analysis presented by the partners in February 2026 showed a conserved ketamine EEG signature in mouse, rat, dog, and human..

合作伙伴于2026年2月提出的一项跨物种分析显示,在小鼠、大鼠、狗和人类中存在保守的氯胺酮脑电图特征。

BELFAST, Northern Ireland and LONDON

北爱尔兰贝尔法斯特和伦敦

,

,

Oct. 14, 2026

2026年10月14日

/PRNewswire/ -- Cumulus Neuroscience, the digital biomarker company behind the NeuLogiq® Platform, and Transpharmation Ltd., a scientist-led preclinical neuroscience contract research organisation (CRO), have entered a strategic partnership to support central nervous system (CNS) drug developers through the preclinical-to-clinical transition.

/美通社/ -- 数字生物标志物公司Cumulus Neuroscience(NeuLogiq®平台的背后企业)与由科学家主导的临床前神经科学合同研究组织(CRO)Transpharmation Ltd.达成战略合作伙伴关系,旨在支持中枢神经系统(CNS)药物开发商顺利完成从临床前到临床的过渡。

The two companies will engage jointly with biopharma sponsors preparing to enter first-in-human studies, aligning the quantitative EEG (qEEG) endpoints and behavioral domains evaluated in Transpharmation's preclinical models with those deployed on the NeuLogiq Platform in the clinic and in participants' homes..

这两家公司将联合与准备开展首次人体试验的生物制药申办方合作,使Transpharmation临床前模型中评估的定量脑电图(qEEG)终点和行为领域与NeuLogiq平台在临床及参与者家中部署的评估内容保持一致。

CNS drug candidates have one of the lowest probabilities of success of any therapeutic area, with an estimated 6.7% progressing from nonclinical development to FDA approval (Sertkaya et al., JAMA Netw Open, 2024). One contributor is a discontinuity in measurement that occurs at precisely the moment a clinical development programme becomes most expensive.

中枢神经系统(CNS)药物候选物的成功率在所有治疗领域中最低,据估计,从非临床开发阶段到获得美国食品药品监督管理局(FDA)批准的比例仅为6.7%(Sertkaya等,《JAMA网络开放》杂志,2024年)。其中一个影响因素是,在临床开发项目成本达到最高的确切时刻,出现了测量上的不连续性。

Preclinically, sponsors generate behavioral and electrophysiological data under tightly controlled conditions. On entering the clinic, the endpoint typically switches to subjective symptom scales and questionnaires, administered infrequently, in heterogeneous populations and noisy settings. When an early clinical study then fails, the sponsor is often unable to determine whether the mechanism was wrong, the exposure inadequate, the endpoint insensitive or the population unsuitable..

在临床前阶段,申办方在严格控制的条件下生成行为学和电生理学数据。进入临床试验阶段后,终点指标通常转变为主观症状量表和问卷,这些指标在异质性人群和嘈杂环境中低频施测。因此,当早期临床研究失败时,申办方往往无法确定究竟是机制错误、暴露量不足、终点指标不敏感,还是研究人群不合适。

EEG offers a route around this discontinuity. It is objective, quantitative, repeatable, and ethologically relevant, and it can be recorded in substantially the same way across species. Transpharmation has a long-established sleep EEG and quantitative EEG (qEEG) platform spanning rodent and canine models, with 26 endpoints benchmarked against clinical gold standards and expertise rooted in its founders' work on orexin and sleep pharmacology at GSK.

脑电图(EEG)为克服这一不连续性提供了一条途径。它具有客观性、定量性、可重复性,且在行为生态学上具有相关性,并能在不同物种间以基本相同的方式进行记录。Transpharmation 拥有一个长期建立的睡眠脑电图和定量脑电图(qEEG)平台,涵盖啮齿类和犬类模型,其26个终点指标均以临床金标准为基准进行对标,其专业能力根植于创始人在葛兰素史克(GSK)期间对食欲素和睡眠药理学研究的工作基础。

Cumulus brings NeuLogiq, a multi-domain digital biomarker platform developed with 10 of the world's leading pharma companies, pairing an FDA 510(k)-cleared, self-applicable wireless dry-EEG headset with tablet-based gamified assessments for use in clinic and at home..

Cumulus 推出 NeuLogiq,这是一个与全球十大领先制药公司合作开发的多领域数字生物标志物平台,将一款获美国食品药品监督管理局(FDA)510(k) clearance、可自助使用的无线干性脑电图(dry-EEG)头戴设备与基于平板电脑的游戏化评估相结合,适用于诊所和家庭场景。

Under the partnership, the two companies will work together with biopharma sponsors from the point at which an asset is transitioning to first-in-human studies. Rather than each company scoping its portion of the programme in isolation, Cumulus and Transpharmation will jointly advise on which EEG paradigms to run preclinically in view of how those same measures will be captured once the molecule reaches the clinic..

根据该合作伙伴关系,两家公司将在资产过渡到首次人体研究阶段时,与生物制药申办方携手合作。Cumulus和Transpharmation将不再各自孤立地界定其负责的项目范围,而是将结合分子进入临床试验后如何采集相同指标的情况,共同就临床前阶段应采用的脑电图(EEG)范式提供建议。

The rationale for the partnership was set out in February 2026, when John Huxter, PhD, Global Head of EEG & Data Science at Transpharmation, and Florentine Barbey, PhD, Senior Scientist at Cumulus Neuroscience, co-presented a cross-species analysis at the

该合作的理由于2026年2月阐明,当时Transpharmation公司全球脑电图与数据科学负责人John Huxter博士与Cumulus Neuroscience公司高级科学家Florentine Barbey博士在会议上共同展示了一项跨物种分析。

6th Annual Psychedelic Therapeutics & Drug Development Conference

第六届迷幻疗法与药物开发年度大会

in New Orleans, using ketamine as a translational probe. In Transpharmation's preclinical datasets, ketamine produced a consistent dose-dependent EEG fingerprint in mouse, rat and dog models: a reduced spectral power in the approximately 10 Hz theta–sigma band and increased power in the 50–100 Hz high-gamma band, with effects tracking an approximately one-hour pharmacokinetic window.

在新奥尔良,使用氯胺酮作为转化探针。在Transpharmation的临床前数据集中,氯胺酮在小鼠、大鼠和犬模型中产生了一致的剂量依赖性脑电图(EEG)特征:约10 Hz的θ–σ频带谱功率降低,50–100 Hz的高γ频带功率增加,其效应与约一小时的药代动力学窗口相吻合。

In a Cumulus study of 30 healthy adult male volunteers, a double-blind crossover design comparing a sub-anaesthetic infusion of racemic ketamine (0.5 mg/kg) with saline produced a quantifiable increase in high-frequency power in the same direction, captured on low-burden dry EEG before, during and after infusion and again at 24 hours, with paired blood sampling enabling direct PK/PD linkage.

在一项由 Cumulus 开展的研究中,30 名健康成年男性志愿者参与了一项双盲交叉设计试验,比较了亚麻醉剂量外消旋氯胺酮(0.5 mg/kg)输注与生理盐水的效果。研究通过低负担干式脑电图(EEG)在输注前、输注期间、输注后以及 24 小时后记录数据,发现高频功率出现了可量化的同向增加;同时,配对血液采样实现了药代动力学/药效学(PK/PD)的直接关联。

A parallel Transpharmation .

平行转化制药。

psilocybin

裸盖菇素

dataset showed selective suppression of REM sleep over four hours matching the time course of plasma psilocin, giving a physiological readout of CNS 5-HT2A target engagement rather than an inference drawn from peripheral exposure alone.

数据集显示,在四小时内对快速眼动(REM)睡眠的选择性抑制与血浆裸盖菇素的时间进程相匹配,从而提供了中枢神经系统5-HT2A靶点参与的生理性读数,而非仅基于外周暴露的推断。

'Our clients benefit from decades of cross-species translational experience, and qEEG has long been one of the most predictive and back-translatable tools we offer,' said Dr Mark Duxon, Chief Executive Officer of Transpharmation. 'What this partnership adds is the other half of the bridge. Working with Cumulus means we can help a client design a preclinical EEG and behavioral package knowing precisely how those endpoints will be captured once the programme reaches the clinic — and that is a conversation worth having before a Phase 1 protocol is finalised, not after the data are in.'.

Transpharmation 首席执行官 Mark Duxon 博士表示:“我们的客户得益于我们在跨物种转化研究方面数十年的经验,而定量脑电图(qEEG)长期以来一直是我们提供的最具预测性且可反向转化的工具之一。此次合作补齐了桥梁的另一半。与 Cumulus 合作意味着我们可以帮助客户设计临床前脑电图和行为学评估方案,并确切了解当项目进入临床试验阶段后将如何捕捉这些终点指标——这种沟通值得在 I 期临床试验方案最终确定之前进行,而不是等到数据出炉之后。”

Continuity of measurement across all phases of clinical development only delivers value if the clinical measurement is deployable at scale. The NeuLogiq Platform is designed for use by non-expert clinic staff and patients, enabling structured sampling in-clinic, and high-frequency longitudinal sampling in the home, without the site burden that would otherwise make robust neurophysiological assessment impractical..

只有在临床测量能够大规模部署的情况下,贯穿临床开发所有阶段的测量连续性才能体现其价值。NeuLogiq 平台专为非专业诊所工作人员和患者设计,支持在诊所内进行结构化采样,并在家庭环境中进行高频纵向采样,同时避免了因站点负担过重而导致稳健的神经生理学评估难以实施的问题。

'Sponsors have never had a shortage of preclinical data — they have had a shortage of preclinical data that still means something the moment the first human is dosed,' said Tina Sampath, Chief Executive Officer of Cumulus Neuroscience. 'Working alongside Transpharmation, we can sit down with a client and align on what will be measured pre-clinically and what NeuLogiq will measure in Phase 1 and beyond.

“赞助商从不缺乏临床前数据,他们缺乏的是在首次人体给药时仍然具有意义的数据。”Cumulus Neuroscience首席执行官Tina Sampath表示。“通过与Transpharmation合作,我们可以与客户坐下来,就临床前阶段将测量什么以及NeuLogiq将在第一阶段及以后测量什么达成一致。”

That gives drug developers something scarce in CNS: a continuous, objective line of evidence that does not break at the species boundary.'.

这为药物开发者提供了中枢神经系统(CNS)领域中稀缺的资源:一条连续、客观的证据链,且不会因物种界限而中断。

Cumulus supports precision in CNS clinical trials for its industry partners by enabling in-clinic and remote monitoring of patients across multiple domains of brain function. Sponsors with CNS assets approaching IND-enabling work or first-in-human study design can contact either company to arrange a joint scoping discussion.

Cumulus 通过实现对患者脑功能多个域的临床内及远程监测,为其行业合作伙伴在中枢神经系统(CNS)临床试验中提供精准支持。拥有中枢神经系统资产、正接近新药临床试验申请(IND) enabling 工作或首次人体试验设计阶段的申办方,可联系任一公司,安排联合范围界定讨论。

To learn more, visit .

如需了解更多,请访问。

www.cumulusneuro.com

www.cumulusneuro.com

.

。

About Quantitative EEG (qEEG)

关于定量脑电图(qEEG)

EEG measures voltage changes generated by the coordinated activity of large populations of neurons, recorded from the scalp or brain surface. Quantitative EEG applies spectral and statistical analysis to those recordings to produce objective measures such as band power, connectivity and phase locking.

脑电图(EEG)测量由大量神经元协同活动产生的电压变化,这些信号从头皮或大脑表面记录。定量脑电图对这些记录应用频谱和统计分析,以产生客观指标,如频段功率、连接性和相位锁定。

Because many CNS-active compounds produce clear dose- and time-dependent effects on specific frequency bands, qEEG can serve as a pharmacodynamic biomarker of target engagement, efficacy and tolerability. Its high predictive and back-translational validity, and the fact that comparable readouts can be obtained in laboratory species and in human participants, make it one of the more directly translatable measures available in CNS drug development..

由于许多作用于中枢神经系统的化合物会对特定频段产生明确的剂量和时间依赖性效应,定量脑电图(qEEG)可作为靶点结合、疗效和耐受性的药效学生物标志物。其高度的预测效度和反向转化效度,以及在实验动物和人类受试者中可获得可比读数的特性,使其成为中枢神经系统药物研发中更具直接转化价值的测量手段之一。

About the Preclinical-to-Clinical Translation Gap

关于临床前至临床转化差距

The transition from preclinical research to first-in-human study is often described as the 'valley of death' in CNS drug development. It is not primarily an indictment of animal models. Failures are more often attributable to insufficient attention to target exposure and engagement, to the complexity of the human clinical population, and to a failure to make use of both human and animal data through common objective measures.

从中枢神经系统(CNS)药物研发的角度来看,从临床前研究过渡到首次人体试验的阶段常被描述为“死亡之谷”。这并非主要归咎于动物模型的缺陷。失败更常归因于对靶点暴露和结合的关注不足、人类临床人群的复杂性,以及未能通过共同的客观指标充分利用人和动物的数据。

Where the measurement system itself changes at the species boundary, a disappointing early clinical result becomes difficult to interpret and therefore difficult to act on..

当测量系统本身在物种边界处发生变化时,令人失望的早期临床结果变得难以解释,因此也难以据此采取行动。

About Cumulus Neuroscience

关于积云神经科学

With a mission to generate the data and insights required to accelerate diagnosis and management of central nervous system (CNS) disorders for millions of patients and caregivers around the world, Cumulus Neuroscience is advancing NeuLogiq®, an AI-based, multi-domain digital biomarker platform to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care.

Cumulus Neuroscience 致力于生成加速全球数百万患者及照护者对中枢神经系统(CNS)疾病诊断与管理所需的数据和洞察,为此公司正在推进 NeuLogiq® 平台的发展。NeuLogiq® 是一个基于人工智能的多领域数字生物标志物平台,旨在助力神经病学和神经精神病学临床试验及患者护理中实现更优质、更高效的决策。

Designed for and with 10 of the world's leading pharma companies, the platform enables .

该平台专为全球十大领先制药企业设计,并与之携手打造,旨在实现。

decentralized

去中心化

trials and is already making a difference in the development of therapies for Alzheimer's Disease, depression and schizophrenia.

试验,并已在阿尔茨海默病、抑郁症和精神分裂症的治疗开发中产生积极影响。

About Transpharmation

关于 Transpharmation

Transpharmation is a contract research organisation led by scientists. Recognised by drug developers worldwide for researching and delivering life-changing medicines, science will always remain our passion. Our clients benefit from decades of experience in cross-species and cross-therapeutic area translational biology throughout our preclinical services.

Transpharmation 是一家由科学家主导的合同研究组织。我们因研发并交付改变生命的药物而受到全球药物开发者的认可,科学始终是我们的热情所在。在我们的临床前服务中,客户受益于我们在跨物种和跨治疗领域的转化生物学方面数十年的经验。

Transpharmation has a strong focus on preclinical evaluation of potential CNS therapeutics including the areas of epilepsy, pain, neurodegeneration, depression, anxiety, schizophrenia and cognition..

Transpharmation 专注于潜在中枢神经系统治疗药物的临床前评估,涵盖癫痫、疼痛、神经退行性疾病、抑郁、焦虑、精神分裂症和认知等领域。

SOURCE Cumulus Neuroscience

来源:Cumulus Neuroscience

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