Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single Intravenous Dose, Parallel Efficacy Study of Apimostinel With or Without Subsequent Automated Self-Association Training in Subjects With Major Depressive Disorder

Apimostinel shows initial promise as a novel rapid-acting antidepressant medication with minimal side effects or safety concerns. Cognitive Training (CT) is a digital intervention that has shown promise in extending the durability of another similar drug (ketamine). This randomized controlled trial will test the efficacy and safety of apimostinel (vs. placebo) for the acute treatment of depression, and will test the potential of CT to enhance and/or extend the durability of apimostinel's antidepressant effect.

开始日期2025-01-01

申办/合作机构

University of Pittsburgh

[+1]

NCT05597241 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled, Single Dose and Multiple Ascending Dose, Single Center Phase1 Study of Safety, Tolerability, Pharmacokinetics, and Electroencephalography of Intravenous GATE-202 in Healthy Volunteers

To evaluate the safety, tolerability, pharmacokinetics and EEG pharmacodynamics of single and multiple ascending doses of apimostinel in normal human volunteers

开始日期2022-10-15

申办/合作机构

Gate Neurosciences, Inc.初创企业

NCT02366364 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled Multiple Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers

The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers.

开始日期2015-02-01

申办/合作机构

Naurex, Inc.

100 项与 Apimostinel 相关的临床结果

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100 项与 Apimostinel 相关的转化医学

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100 项与 Apimostinel 相关的专利（医药）

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项与 Apimostinel 相关的文献（医药）

2019-06-01·IBRO reports

Review

作者: Fasipe, Olumuyiwa John

This study was designed with the rational aim of discussing the emerging antidepressant agents that are likely to bring positive landmark, tremendous improvement and significant impact to the management of patients with depression disorders. It also elaborates on the Agomelatine paradox vis-a-vis the other novel antidepressant agents. The emerging antidepressants are: selective monoamine oxidase inhibitors (MAOIs) such as bifemelane, pirlindole, toloxatone, selegiline, rasagiline and safinamide; serotonin-norepinephrine reuptake inhibitors (SNRIs) such as ansofaxine, nefopam and levomilnacipran; norepinephrine reuptake inhibitors (NRIs) such as Reboxetine, viloxazine, teniloxazine (also known as sulfoxazine or sufoxazine), and atomoxetine; Vilazodone (a serotonin 5-HT_1A autoreceptor partial agonist with serotonin reuptake inhibition [SPARI]); Vortioxetine (a serotonin receptors antagonist with serotonin reuptake inhibition [SARI]); atypical antipsychotics such as olanzapine, quetiapine, risperidone, lurasidone, aripiprazole and brexpiprazole; N-methyl-d-aspartate (NMDA)-glutamatergic neurotransmission system blockers such as ketamine, CP-101,606 (traxoprodil), GLYX-13 (rapastinel), NRX-1074 (Apimostinel) and Riluzole. While Agomelatine (a melatonergic MT ₁ and MT ₂ receptors agonist and a selective serotonergic 5-HT _2B and 5-HT _2C receptors antagonist [MASSA]) remains a paradoxical agent that doesn't fit into any of the currently available classes of antidepressant agents and its pharmacological properties also deemed it unfit and inappropriate to be classified into another separate novel class of antidepressants contrary to the reports published in previous reference literatures. Lastly, this review remarkably advocates for the incorporation of the atypical antipsychotics and NMDA-glutamatergic ionoceptor blockers as new member classes of the antidepressant agents because of their clinically significant roles in the management of depression disorders.

2019-02-01·Drug discovery today2区 · 医学

2区 · 医学

Review

作者: Sanacora, Gerard ; Wilkinson, Samuel T

Mood disorders represent the largest cause of disability worldwide. The monoaminergic deficiency hypothesis, which has dominated the conceptual framework for researching the pathophysiology of mood disorders and the development of novel treatment strategies, cannot fully explain the underlying neurobiology of mood disorders. Mounting evidence collected over the past two decades suggests the amino acid neurotransmitter systems (glutamate and GABA) serve central roles in the pathophysiology of mood disorders. Here, we review progress in the development of compounds that act on these systems as well as their purported mechanisms of action. We include glutamate-targeting drugs, such as racemic ketamine, esketamine, lanicemine (AZD6765), traxoprodil (CP-101,606), EVT-101, rislenemdaz (CERC-301/MK-0657), AVP-786, AXS-05, rapastinel (formerly GLYX-13), apimostinel (NRX-1074/AGN-241660), AV-101, NRX-101, basimglurant (RO4917523), decoglurant (RG-1578/RO4995819), tulrampator (CX-1632/S-47445), and riluzole; and GABA-targeting agents, such as brexanolone (SAGE-547), ganaxolone, and SAGE-217.

2016-03-01·Annales pharmaceutiques francaises

Psychopharmacologie de l’anxiété et de la dépression : aspects historiques, traitements actuels et perspectives

Review

作者: Javelot, H

Pharmacological treatment of acute anxiety still relies on benzodiazepines, while chronic anxiety disorders and depression are treated with different antidepressants, according to specific indications. The monoaminergic axis is represented by two families which are being developed: (i) serotonin-norepinephrine-dopamine reuptake inhibitors (SNDRI), also called triple reuptake inhibitors (TRI), for the treatment of depression (amitifadine), (ii) multimodal antidepressants for depression and anxiety disorders (generalized anxiety disorder mainly) (tedatioxetine, vortioxetine and vilazodone). Third-generation antipsychotics (aripiprazole, lurasidone, brexpiprazole, cariprazine) appear relevant in the treatment of resistant depression and some anxiety disorders. Among the modulators of the glutamatergic axis, promising compounds include: (i) ionotropic regulators of NMDA receptors: esketamine, AVP-923 and AVP-786, CERC-301, rapastinel (Glyx-13), NRX-1074 developed for depression, rapastinel and bitopertine developed for obsessive compulsive disorder, (ii) metabotropic glutamate receptors modulators: decoglurant and basimglurant developed for depression and mavoglurant developed for obsessive compulsive disorder.

项与 Apimostinel 相关的新闻（医药）

2024-09-12

·药精通Bio

全球在研小分子抗抑郁症新药盘点

Apimostinel CAS : 1421866-48-9 机理：NMDA受体部分激动剂状态：II期（IV）和I期（口服）临床试验开发者：Allergan 也称为NRX-1074，是一种最初由Naurex开发的用于治疗抑郁症的药物-但目前正在由Naurex和Allergan（收购Naurex）共同研究。该药物对NMDA受体具有选择性的部分激动剂的功能，特别是在甘氨酸结合位点的变构位点。虽然Apimostinel表现出GLYX-13（另一种正在由Naurex开发的药物）相似的作用机制，但它与GLYX-13的不同之处在于其重量更显着。一项比较分析表明，按重量计，Apimostinel的效力是GLYX-13的数千倍。之前我已经讨论了使用NRX-1074来治疗抑郁症的潜在好处，并提到它起效快，没有拟精神病作用并且似乎耐受良好。初步证据表明，服用Apimostinel后，抑郁症状可能在24小时内消失。此外，Apimostinel的情绪增强作用似乎是剂量依赖性的，因此更高剂量的抗抑郁作用更为明显。值得一提的是，在早期试验中，单剂量的Apimostinel提供的缓解抑郁症状的症状要比SSRIs持续数周的缓解率更高。 BTRX-246040 CAS : 1307245-86-8 机理: NOC 受体拮抗剂状态: Phase II 开发者: BlackThorn Therapeutics 该药物最初由礼来公司进行研究，但现在似乎与黑刺李疗法联系在一起，并有了一个新的化学名称。2016年发表的一项概念验证研究报告称，LY-2940094(40毫克)是安全的，耐受性好，对治疗人类抑郁症有效——持续时间超过8周。它作为一种抗抑郁药物的初步疗效通过格里-汉密尔顿抑郁评分量表(GRID-Hamilton Depression Rating scale)从基线到8周的17个总分的显著变化得到证明。此外，研究还发现LY-2940094在治疗的第一周内改变了对情绪刺激的处理——在情绪测试系列中，对积极面部表情相对于消极面部表情的认知增强就是证据。LY-2940094的初步调查数据是第一批显示NOP受体拮抗剂治疗抑郁症的潜力的数据。关于BTRX-246040是否将继续用于治疗重度抑郁症，还是将其作为治疗其他神经系统疾病的治疗手段而接受调查，还存在一些争议。然而，与大多数抗抑郁药物相比，BTRX-246040表现出独特的作用机制。拮抗NOC受体似乎能增加大脑几个区域的单胺浓度，增强神经发生，并调节下丘脑-垂体-肾上腺轴的激活。 CERC-301 CAS : 808732-98-1 机理: NMDA 受体 (NR2B-selective) 拮抗剂状态: Phase II 开发者: Cerecor 2013年，FDA授予CERC-301“快速通道指定”，作为抑郁症和自杀意念的潜在辅助治疗药物。药效学研究表明，CERC-301对NMDA受体NR2B亚基具有高选择性拮抗作用。它对NMDA受体NR2B亚基的选择性亲和性被认为可以最大限度地降低与其他非选择性NMDA受体拮抗剂共同发生的拟精神分裂效应(如药物诱导的精神病)的可能性。 CERC-301的显影剂Cerecor表明，CERC-301具有快速的抗抑郁活性，从而在给药几分钟或几小时内就能缓解抑郁症状，而不是几天或几周。来自CERC-301试验的初步数据表明，该药物耐受性良好且安全。许多人认为，CERC-301是正在开发的治疗抑郁症的NMDA拮抗剂中最有前途的。 CERC-501 CAS : 1174130-61-0 机理: KOR 拮抗剂状态: Phase III 开发者: Janssen CERC-501是美国礼来公司首次研发的药物，名为LY-2456302。然而，在2015年2月，礼来公司将LY-2456302卖给了Cerecor公司，后者将其更名为CERC-501。2016年，CERC-501作为一种抗抑郁II期临床试验难治性抑郁症患者达到效果。截至2017年8月，Cerecor将CERC-501出售给了Janssen Pharmaceuticals，后者正在继续开发其作为抑郁症的辅助疗法和药物滥用障碍的干预疗法。药效学评估显示，CERC-501是一种选择性的、短效的KOR (kappa阿片受体)拮抗剂。研究表明，激活kappa类阿片受体(KORs)会引发烦躁、幻觉和精神幻像效应——同时也会强化神经化学系统，与奖赏缺乏综合症、慢性压力和重度抑郁症有关。用CERC-501拮抗kappa阿片受体(KOR)可能通过抵消已有的kappa阿片受体激活而促进抗抑郁效果。CERC-501与其他抗抑郁药(如SSRIs)联合使用可产生协同情绪增强作用(或比单独使用任何一种药物效果更好)。有报道称，在三期临床试验中，CERC-501的副作用不严重。 Liafensine (DB104) CAS:1198790-53-2 机理: SNDRI 状态: Phase II 开发者: Denovo Biopharma Liafensine (DB104)，原名BMS-820836，是一种SNDRI(5 -羟色胺-去甲肾上腺素-多巴胺再摄取抑制剂)或三层再摄取抑制剂，最初由AMRI开发，授权给百时美施贵宝治疗重度抑郁症。通过二期临床试验，该药物表现出与依西酞普兰(即依地普仑)和度洛西汀(即欣百达)相似的疗效。但百时美施贵宝终止其开发，主要原因是其疗效并不明显优于依地普乐和欣百达。它的疗效相对于副作用和滥用潜力可能是Liafensine 被百时美施贵宝停止开发的原因。2017年，Denovo Biopharma获得了Liafensine的许可权，三重再摄取抑制剂的二期临床试验仍在继续。 JNJ-39393406 CAS : 953428-73-4 机理: Alpha-7 nAChR 调制器状态: Phase II 开发者: Janssen JNJ-39393406用于治疗重度抑郁症和戒烟。与目前市场上大多数抗抑郁药相比，JNJ-39393406的独特之处在于，它仅作为-7烟碱乙酰胆碱受体的选择性正变构调制器(PAM)。药效学研究表明，该药物不会与-4-beta-2或-3-beta-4尼古丁乙酰胆碱受体或- 5-HT3受体相互作用。更重要的是，药物似乎并没有与62种受体和酶相互作用。截至2018年2月，JNJ-39393406正在进行治疗重度抑郁症和尼古丁戒断的II期临床试验。JNJ-39393406以前被研究作为阿尔茨海默病和精神分裂症的干预措施，但是，经评估后被放弃了。 Ansofaxine (LY03005) CAS : 916918-84-8 机理: SNDRI 状态: Phase I 开发者: 绿叶制药盐酸Ansofaxine(LY03005)是绿叶制药集团开发的用于治疗中重度抑郁症的三重摄取抑制剂(5 -羟色胺-去甲肾上腺素-多巴胺)。对Ansofaxine的药效学评价表明，它具有SNDRI的作用，是去文拉法辛的前药。然而，与去文拉法辛(即Pristiq)相比，Ansofaxine在同时调节血清素和去甲肾上腺素的同时，具有显著的多巴胺能效应。到目前为止，Ansofaxine已经在两个人体试验中进行了评估，分别有72名和48名参与者。从现有的I期试验数据来看，Ansofaxine在40毫克至160毫克的剂量下似乎具有良好的耐受性和安全性。绿叶制药集团认为，与目前市面上的抗抑郁药相比，这种新药的副作用更少，起效更快。 MIN-117 CAS : 310392-93-9 机理: SDRI 状态: Phase II 开发者: Minerva Neurosciences MIN-117是一种血清素-多巴胺调制器，由Minerva神经科学公司开发用于治疗重度抑郁症。其作用机制针对受体和转运体的结合，包括:α- 1a受体;α-1B受体;5-HT2A受体;SERT(羟色胺转运体);和DAT(多巴胺转运体)。具体来说，MIN-117被证明是一种5-HT1A和5-HT2A拮抗剂;血清素和多巴胺再摄取抑制剂;α- 1a和α- 1b肾上腺素能受体调节剂。 Minerva神经科学提示MIN-117旨在解决重性抑郁症伴有共病焦虑或焦虑症状的患者的未控制症状。开发人员推测MIN-117将比目前市场上的大多数抗抑郁药物反应更快、更安全、耐受性更好。目前MIN-117作为干预抑郁症的临床试验正处于II期。 Seltorexant (MIN-202) CAS : 1293281-49-8 机理: Orexin-2 拮抗剂状态: Phase II (complete) 开发者: Minerva Neurosciences & Janssen Seltorexant，又称MIN-202 (Minerva)和JNJ-42847922或JNJ-922 (Janssen)，是一种正在研究中的小分子、选择性orexin受体拮抗剂，由Minerva神经科学和Janssen开发。临床试验正在评估Seltorexant对重度抑郁症和失眠的治疗效果。据开发人员介绍，Seltorexant可以阻断大脑中促进觉醒的神经元的激活，特别是通过与orexin 2 (Orx-2)受体结合。 NSI-189 CAS : 1270138-40-3 机理: 神经发生诱导物状态: Phase III (?) 开发者: Neuralstem Inc. NSI-189是由Neuralstem公司开发的一种实验性药物，用于治疗重度抑郁症、认知障碍和神经退行性疾病。NSI-189是通过超过10000个化合物筛选，以确定哪些在体外(细胞)诱导最大程度的神经发生。NSI-189在体外和啮齿类动物中都表现出了疗效，随后将在患有重度抑郁症的人身上进行测试。在II期临床试验中，NSI-189通过降低220名重性抑郁症患者的MADRS评分而未能达到其主要终点。NSI-189仍将继续接受神经系统和中枢神经系统疾病的治疗评估，包括:神经病、缺血性中风和认知障碍。 Rapastinel (GLYX-13) CAS : 117928-94-6 机理: NMDA 受体调制器状态: Phase III 开发者: Allergan Rapastinel(原名GLYX-13)是Allergan公司开发的一种药物(在收购Allergan之前由Naurex公司进行测试)，作为治疗耐药性抑郁症(或对2种或2种以上一线干预无效的抑郁症)的辅助干预手段。这种药物在口服时是不活跃的，而在静脉注射时是特别设计的。它在NMDA受体复合物的甘氨酸亚基的变构位点起选择性、适度的局部激动剂(混合拮抗剂/激动剂)的作用。初步证据表明Rapastinel作用快速，并产生长期的抗抑郁反应。此外，Rapastinel似乎是通过抑制和增强NMDA受体介导的信号转导而增强认知功能的。无论动物年龄多大，给动物服用Rapastinel能增强记忆和学习能力，还能促进神经保护作用。 Rapastinel被归类为一种glyxin化合物，来源于修改单克隆抗体的结构，调节NMDA受体，称为“B6B21”。基于初步的试验数据，Rapastinel是治疗难治性抑郁症最有希望的治疗手段之一。 SAGE-217 CAS : 1632051-40-1 机理: GABAA受体调制器状态: Phase III 开发者: Sage Therapeutics Sage -217是由Sage Therapeutics公司研发的一种研究性化学药物，用于治疗重度抑郁症和产后抑郁症，以及帕金森病、失眠和癫痫的原发性震颤。据Sage Therapeutics公司介绍，Sage -217是一种合成的孕烷神经类固醇，它是GABAA受体的一种正变构调制器。SAGE-217的目标是改进并继承Brexanolone ——另一种圣人治疗抑郁症的药物，目前已进入临床试验阶段。在用于治疗女性产后抑郁症(PPD)患者的3期试验ROBIN中，达到了试验的主要和次要终点。重症抑郁三期失败。 Travivo (Gepirone ER) CAS:83928-66-9;83928-76-1 机理: 5-HT1A 选择性部分激动剂状态: 等待 FDA 批准开发者: Fabre-Kramer Pharmaceuticals Travivo (Gepirone ER)是一种抗抑郁药物，最初因疗效问题被FDA多次拒绝。它第一次被否决是在2004年，然后在2007年再次被否决。FDA在2015年审查了Gepirone的数据，推翻了他们最初对该药物的排斥——给予了有利的评价。2016年3月FDA对Travivo (Gepirone ER)治疗重度抑郁症的疗效进行了有利的规定。参考原文：30+ New Antidepressants (2018): Drugs In Clinical Trials TIS2024第四届自免疾病细胞疗法与干细胞疗法论坛重磅来袭，点击图片查看重磅嘉宾，合作详询：王晨 180 1628 8769 （扫码立即报名获取TIS2024免费票）

临床2期快速通道临床1期并购

2024-05-15

·BioSpace

Gate Neurosciences to Share New Data and Research Insights on its Synaptic Function Molecules with Multiple Posters at 2024 ASCP Annual Meeting

Two poster presentations will feature novel findings of preclinical metaplasticity research and updated data from the recent apimostinel Phase 1 qEEG biomarker study Company will host its 3rd annual R&D Day with investigators and key opinion leaders to share new insights ahead of an upcoming Phase 2 MDD study with zelquistinel INDIANAPOLIS--(BUSINESS WIRE)-- Gate Neurosciences, Inc., a clinical-stage biotechnology company using precision medicine to develop next-generation neuroscience therapies, today announced upcoming activities at the 2024 annual meeting of the American Society of Clinical Psychopharmacology (ASCP), being held in Miami Beach, FL, from May 28-31, 2024. The company will present new preclinical and clinical data supporting its NMDAR PAM portfolio and will share novel insights from internal research on the biological mechanisms of neuroplasticity and synaptic function. Specifically, Gate Neurosciences will highlight its cutting-edge research on how a single dose of neuroplasticity-enhancing drugs can trigger both rapid-onset (i.e. hours) and long-lasting therapeutic effects (i.e. weeks), a phenomenon termed ‘event-driven pharmacology’. Gate’s new preclinical and clinical insights have yielded critical findings on CNS-specific ‘event-driven pharmacology’ and the importance of dosing intervals to optimize plasticity treatments. The company plans to share these new insights at its 3rd annual R&D Day at the conference with leading members of the scientific community in attendance. The session will also include updates on an upcoming Phase 2 study with a once-weekly oral program, zelquistinel (GATE-251), for Major Depressive Disorder. Gate Neurosciences 3rd Annual R&D Day at ASCP 2024: Location: Loews Hotel Miami Beach, Florida Date: Tuesday, May 30, 2024 Time: 12:15 p.m. to 1:45 p.m. “Over the past few years, the Gate team has made considerable progress in understanding mechanisms that rapidly and durably enhance synaptic function for treating CNS diseases. Dosing these compounds the right way is critical to success,” stated Mike McCully, CEO of Gate Neurosciences. “We look forward to sharing our new data and insights with the psychiatry community at the ASCP conference and discussing updated plans for our Phase 2 study of once-weekly oral zelquistinel in depression.” Poster Presentation Details: Poster #T14 Title: Apimostinel, a Novel NMDAR Modulator with Rapid-Acting, Sustained Effects and Favorable Drug-Like properties: Preclinical Studies Abstract Number: T14 Presentation Session: Poster Session II, Salon 4 Presentation Date and Time: 12:30pm – 2:25pm, Thursday May 30th 2024 Lead Author: Jeffrey Burgdorf, PhD Poster #T14 details new preclinical data supporting apimostinel as an acute psychiatry drug candidate with lasting metaplasticity effects. Key takeaways include: Single dose of apimostinel acutely enhanced LTP with metaplasticity lasting 7 days, and produced robust antidepressant-like effects without ketamine-like side effects Apimostinel dose-dependently enhanced qEEG alpha in correlation with CSF exposure, as a biomarker of NMDA receptor target activation Repeat doses of apimostinel led to larger and longer-lasting metaplastic effects At the Society of Biological Psychiatry (SOBP) Annual Meeting earlier this month, Gate presented additional data on the specific NMDAR PAM mechanism of action of apimostinel. Poster #T21 Title: A Phase 1 Safety, Pharmacokinetics (PK) and Quantitative Electroencephalography (qEEG) Pharmacodynamics Study of Single and Multiple Ascending Doses of Intravenous Apimostinel Compared with Placebo in Healthy Volunteers Abstract Number: T21 Presentation Session: Poster Session II, Salon 4 Presentation Date and Time: 12:30pm – 2:25pm, Thursday May 30th 2024 Lead Author: Ronald M. Burch, MD PhD Poster #T21 is the first scientific presentation of findings from the apimostinel Phase 1 clinical trial assessing safety and qEEG biomarkers. Key takeaways include: Apimostinel was generally safe and well-tolerated following multiple doses from 1-25mg Apimostinel dose-dependently stimulated qEEG alpha power qEEG alpha power stimulation with apimostinel was consistent with CSF Cmax drug concentrations that maximally stimulate NMDA receptors in vitro qEEG alpha power stimulation with apimostinel was consistent with efficacious doses in a previous Phase 2a clinical MDD study Full abstracts will be published by ASCP following the conclusion of the 2024 Annual Meeting. About Gate Neurosciences Gate Neurosciences, headquartered in Indianapolis, is a precision medicine biotechnology company focused on advancing next-generation central nervous system (CNS) treatments that address the growing needs in mental health. The company is developing a portfolio of novel mechanisms of action that enhance synaptic function to address neuropsychiatric and neurocognitive diseases, including major depressive disorder. Using learnings from extensive clinical, preclinical and translational data, along with a better understanding of CNS development challenges, the company is advancing its clinical pipeline using evidence-driven, precision psychiatry approaches.

临床1期临床2期ASCO会议临床结果

2024-01-24

·BioSpace

Gate Neurosciences Announces Clinical Collaboration with Beacon Biosignals to Advance Precision EEG Biomarkers in Major Depressive Disorder

Collaboration entails the use of Beacon Biosignals’ FDA-cleared DreemTM 3S device in an upcoming Phase 2 clinical trial of Gate's lead oral program, zelquistinel, in Major Depressive Disorder INDIANAPOLIS--(BUSINESS WIRE)-- Gate Neurosciences, Inc., a clinical-stage biotechnology company using precision medicine approaches to develop next-generation neuroscience therapies, today announced a strategic collaboration with Beacon Biosignals to further advance the use of electroencephalogram (EEG) biomarkers across the company’s clinical pipeline in neuropsychiatry and cognition. Initially, this collaboration will entail the use of Beacon Biosignals’ FDA-cleared Dreem™ 3S headband device and neurobiomarker platform to conduct exploratory EEG and sleep analyses in depressed patients enrolled in Gate’s upcoming Phase 2 trial of zelquistinel, slated to initiate by mid-2024. Zelquistinel is a rapid-acting, once-weekly oral NMDA receptor positive modulator in development for treating major depressive disorder (MDD). “The Gate team is excited to partner with Beacon in pioneering a new era of precision psychiatry with innovative biomarker insights, approaches, and technology,” commented Mike McCully, CEO of Gate Neurosciences. “We will apply data and key learnings obtained from our combined experience in psychiatric clinical studies and EEG analyses to ultimately improve outcomes for patients across mental health, cognitive, and neurodevelopmental disorders.” The collaboration represents the next phase of precision psychiatry for Gate, building on its existing biomarker research including EEG data from prior zelquistinel clinical studies and translational EEG insights at the company’s recently expanded R&D operations in Evanston, Illinois. In November of 2023, the company announced positive results from a Phase 1 EEG biomarker study of apimostinel (second-generation injectable NMDA receptor modulator), which demonstrated a consistent, dose-dependent human EEG signature representing NMDAR target activation. In the upcoming zelquistinel Phase 2 depression study, Gate will use Beacon’s biomarker platform for deeper insights into patient diagnoses, treatment response, and target activation over six weeks of dosing. “In psychiatry, outcomes can vary widely within the same diagnosis; making it difficult for patients, families, and providers to determine the best treatment pathway for any individual,” said Jacob Donoghue, M.D., Ph.D., CEO of Beacon Biosignals. “Brain activity during sleep, as measured using Beacon’s at-home hardware and AI-powered software, will provide a level of precision understanding never before possible, empowering informed and accurate decisions for the treatment of conditions such as depression. We look forward to working with the team at Gate on the upcoming clinical trial for zelquistinel, and to making further progress on this cutting-edge research.” Beacon Biosignals’ analytics platform combines its large clinical EEG databases and proprietary machine-learning algorithms to identify neurobiomarkers that assist with patient stratification, assessing drug activity and therapeutic efficacy. A key component of this platform is the Dreem™ 3S EEG device, which is U.S. Food and Drug Administration cleared and clinically validated. The wearable device measures sleep architecture and EEG activity in patients with central nervous system disorders and is optimized for comfortable, longitudinal brain monitoring. The Dreem™ 3S data flows into Beacon Biosignals' analytics platform to provide validated neurophysiological endpoints for clinical trials. About Gate Neurosciences Gate Neurosciences, headquartered in Indianapolis, is a precision medicine biotechnology company focused on advancing next-generation central nervous system (CNS) treatments that address the growing needs in mental health. The company is developing a portfolio of novel mechanisms of action that enhance synaptic function to address neuropsychiatric and neurocognitive diseases, including major depressive disorder. Using learnings from extensive clinical, preclinical and translational data, along with a better understanding of CNS development challenges, the company is advancing its clinical pipeline using evidence-driven, precision psychiatry approaches. About Beacon Biosignals Beacon's machine learning platform for EEG enables and accelerates new treatments that transform the lives of patients with neurological, psychiatric or sleep disorders. Through novel machine learning algorithms, large datasets, and advances in software engineering, Beacon Biosignals is changing the way patients are treated for disorders of the brain. For more information, visit . For careers, visit ; for partnership inquiries, visit . Follow us on Twitter (@Biosignals) or LinkedIn ( ).

临床2期临床1期

100 项与 Apimostinel 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11299	Apimostinel	-	DB11784

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适应症	最高研发状态	国家/地区	公司	日期
精神分裂症	临床2期	美国	Naurex, Inc.	2015-11-11
重度抑郁症	临床2期	美国	Naurex, Inc.	2014-03-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02067793 (Biospace) 人工标引	临床2期	重度抑郁症	151	Apimostinel	衊憲願顧齋廠艱夢夢繭(鏇齋獵蓋獵襯鬱蓋襯襯): difference = 5.4, P-Value = 0.0034 更多	积极	2022-09-29
				Placebo