A Two-Part, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose (Part A) or Twice Daily Dose (Part B) Study of AGN-241751 in Adult Participants With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy and safety of AGN-241751 in participants with Major Depressive Disorder

开始日期2018-11-08

申办/合作机构

Gate Neurosciences, Inc.初创企业

NCT03586427 / Completed临床2期

A Double-Blind, Placebo-Controlled, Fixed-Dose Study of AGN-241751 in Adult Participants With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy at 1 day post initial oral dose of AGN-241751 compared with placebo in participants with Major Depressive Disorder (MDD).

开始日期2018-06-13

申办/合作机构

Gate Neurosciences, Inc.初创企业

NCT04981561 / Completed临床1期

A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AGN-241751 After Oral Administration in Healthy Volunteers

To evaluate the safety and tolerability of single ascending doses of GATE-251 in normal human volunteers

开始日期2016-12-09

申办/合作机构

Gate Neurosciences, Inc.初创企业

100 项与 Zelquistinel 相关的临床结果

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100 项与 Zelquistinel 相关的转化医学

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100 项与 Zelquistinel 相关的专利（医药）

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项与 Zelquistinel 相关的文献（医药）

2022-12-12·The international journal of neuropsychopharmacology

Zelquistinel Is an Orally Bioavailable Novel NMDA Receptor Allosteric Modulator That Exhibits Rapid and Sustained Antidepressant-Like Effects

Article

作者: Stanton, Patric K ; Moskal, Joseph R ; Donello, John E ; Burgdorf, Jeffrey S ; Zhang, Xiao-Lei

Abstract:

Background:

The role of glutamatergic receptors in major depressive disorder continues to be of great interest for therapeutic development. Recent studies suggest that both negative and positive modulation of N-methyl-D-aspartate receptors (NMDAR) can produce rapid antidepressant effects. Here we report that zelquistinel, a novel NMDAR allosteric modulator, exhibits high oral bioavailability and dose-proportional exposures in plasma and the central nervous system and produces rapid and sustained antidepressant-like effects in rodents by enhancing activity-dependent, long-term synaptic plasticity.

Methods:

NMDAR-mediated functional activity was measured in cultured rat brain cortical neurons (calcium imaging), hNR2A or B subtype-expressing HEK cells, and synaptic plasticity in rat hippocampal and medial prefrontal cortex slices in vitro. Pharmacokinetics were evaluated in rats following oral administration. Antidepressant-like effects were assessed in the rat forced swim test and the chronic social deficit mouse model. Target engagement and the safety/tolerability profile was assessed using phencyclidine-induced hyperlocomotion and rotarod rodent models.

Results:

Following a single oral dose, zelquistinel (0.1–100 µg/kg) produced rapid and sustained antidepressant-like effects in the rodent depression models. Brain/ cerebrospinal fluid concentrations associated with zelquistinel antidepressant-like activity also increased NMDAR function and rapidly and persistently enhanced activity-dependent synaptic plasticity (long-term potentiation), suggesting that zelquistinel produces antidepressant-like effects by enhancing NMDAR function and synaptic plasticity. Furthermore, Zelquistinel inhibited phencyclidine (an NMDAR antagonist)-induced hyperlocomotion and did not impact rotarod performance.

Conclusions:

Zelquistinel produces rapid and sustained antidepressant effects by positively modulating the NMDARs, thereby enhancing long-term potentiation of synaptic transmission.

2021-05-01·CNS drugs2区 · 医学

Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status

2区 · 医学

Review

作者: Zarate, Carlos A ; Park, Lawrence T ; Henter, Ioline D

The efficacy of standard antidepressants is limited for many patients with mood disorders such as major depressive disorder (MDD) and bipolar depression, underscoring the urgent need to develop novel therapeutics. Both clinical and preclinical studies have implicated glutamatergic system dysfunction in the pathophysiology of mood disorders. In particular, rapid reductions in depressive symptoms have been observed in response to subanesthetic doses of the glutamatergic modulator racemic (R,S)-ketamine in individuals with mood disorders. These results have prompted investigation into other glutamatergic modulators for depression, both as monotherapy and adjunctively. Several glutamate receptor-modulating agents have been tested in proof-of-concept studies for mood disorders. This manuscript gives a brief overview of the glutamate system and its relevance to rapid antidepressant response and discusses the existing clinical evidence for glutamate receptor-modulating agents, including (1) broad glutamatergic modulators ((R,S)-ketamine, esketamine, (R)-ketamine, (2R,6R)-hydroxynorketamine [HNK], dextromethorphan, Nuedexta [a combination of dextromethorphan and quinidine], deudextromethorphan [AVP-786], axsome [AXS-05], dextromethadone [REL-1017], nitrous oxide, AZD6765, CLE100, AGN-241751); (2) glycine site modulators (D-cycloserine [DCS], NRX-101, rapastinel [GLYX-13], apimostinel [NRX-1074], sarcosine, 4-chlorokynurenine [4-Cl-KYN/AV-101]); (3) subunit (NR2B)-specific N-methyl-D-aspartate (NMDA) receptor antagonists (eliprodil [EVT-101], traxoprodil [CP-101,606], rislenemdaz [MK-0657/CERC-301]); (4) metabotropic glutamate receptor (mGluR) modulators (basimglurant, AZD2066, RG1578, TS-161); and (5) mammalian target of rapamycin complex 1 (mTORC1) activators (NV-5138). Many of these agents are still in the preliminary stages of development. Furthermore, to date, most have demonstrated relatively modest effects compared with (R,S)-ketamine and esketamine, though some have shown more favorable characteristics. Of these novel agents, the most promising, and the ones for which the most evidence exists, appear to be those targeting ionotropic glutamate receptors.

2021-03-01·Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology1区 · 医学

Positive modulation of NMDA receptors by AGN-241751 exerts rapid antidepressant-like effects via excitatory neurons

1区 · 医学

Article

作者: Pothula, Santosh ; Duman, Ronald S ; Liu, Rong-Jian ; Banerjee, Pradeep ; Sliby, Alexa-Nicole ; Wu, Min ; Picciotto, Marina R

Dysregulation of the glutamatergic system and its receptors in medial prefrontal cortex (mPFC) has been implicated in major depressive disorder. Recent preclinical studies have shown that enhancing NMDA receptor (NMDAR) activity can exert rapid antidepressant-like effects. AGN-241751, an NMDAR positive allosteric modulator (PAM), is currently being tested as an antidepressant in clinical trials, but the mechanism and NMDAR subunit(s) mediating its antidepressant-like effects are unknown. We therefore used molecular, biochemical, and electrophysiological approaches to examine the cell-type-specific role of GluN2B-containing NMDAR in mediating antidepressant-like behavioral effects of AGN-241751. We demonstrate that AGN-241751 exerts antidepressant-like effects and reverses behavioral deficits induced by chronic unpredictable stress in mice. AGN-241751 treatment enhances NMDAR activity of excitatory and parvalbumin-inhibitory neurons in mPFC, activates Akt/mTOR signaling, and increases levels of synaptic proteins crucial for synaptic plasticity in the prefrontal cortex. Furthermore, cell-type-specific knockdown of GluN2B-containing NMDARs in mPFC demonstrates that GluN2B subunits on excitatory, but not inhibitory, neurons are necessary for antidepressant-like effects of AGN-241751. Together, these results demonstrate antidepressant-like actions of the NMDAR PAM AGN-241751 and identify GluN2B on excitatory neurons of mPFC as initial cellular trigger underlying these behavioral effects.

项与 Zelquistinel 相关的新闻（医药）

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

2024-04-02

·研发客

CNS如何用AI找精准患者？| 行业观察

// 从1期临床至上市成功率仅有5.9%的CNS药物，AI为其开辟了新机遇，包括难以在CNS领域应用的靶向疗法。“知识驱动的常规药物研发模式在CNS领域遭遇瓶颈期，加之过去15年积累的疾病组学和药物临床大数据，因而给予了数据驱动CNS药物研发新契机。”普百思生物创始人包杨欢如是分析。利用AI驱动CNS疾病研发，目前国内外均已有企业布局，且已有部分成果出现：一是从已有研究数据中筛选和验证老药的新途径，预测药物联用组合的疗效和副作用；二是发现新靶点和新机理；三是为特定患者亚群匹配更可能有效的药物。筛选生物标志物多年的基因组和遗传学研究表明，除了ALS、亨廷顿病、家族性AD等只有少数几种亚型，大部分CNS疾病的风险基因有上百个，每个都对发病产生一定程度的贡献，且各致病基因间相互关系并不清楚。这也意味着，类似针对“驱动基因”的肿瘤靶向疗法在CNS领域很难推广开来，给CNS疾病新机理的开发增加了更多难度。但也正是各类CNS疾病之间存在很强的关联性，底层生物学致病机制存在相通之处，包杨欢认为，CNS药物研发应着重靶向这些机制，即CNS疾病的“靶向疗法”。连接这些疾病的底层机制是什么？包杨欢做出解释。普百思创始人包杨欢在中枢神经上游的压力应激、神经免疫炎症和下游的神经突触损伤三个通路中，各类疾病都存在相同之处，例如抑郁症、精神分裂、双向情感障碍、阿尔茨海默病等疾病，压力激素失调、神经免疫炎症指标偏高、神经突触损伤导致的认知受损，在相当一部分患者中能检测出来，这正是“靶向疗法”瞄准的精准亚群。以“房屋着火”解释三个通路的原理。“房屋着火”时，最明显标志是中游的“火焰”，这是目前研究较多的方向，例如精神类药物靶向的神经递质和AD药物靶向的错误折叠蛋白。而如果只针对火焰，可能暂时扑灭，但无法完全解决问题。上游没被熄灭的“火源”（应激和炎症）容易复燃，下游对房屋造成的损伤没被修复（突触、神经、髓鞘损伤），疾病也不能完全被治愈。以神经突触损伤通路为例。当突触功能损伤后易导致认知功能障碍，斯坦福大学研究人员在重度抑郁症（MDD）中发现一类认知受损亚群，占MDD患者约27%，且对常规治疗反应不佳。该领域中已有企业开启研究，Alto Neuroscience公司的ALTO-100就是治疗以神经认知损伤为特征的MDD患者。由此也体现出生物标志物筛选的重要性，富集出与有效药物发挥疗效相匹配的亚群。富集用药人群越精准，临床获益越好。ALTO-100的2a数据显示，单药治疗时，81%神经认知受损的患者获得临床应答，而一般患者只有38%。另一款以脑电生物标志物为特征的ALTO-300，其2a期临床试验发现，通过生物标志物识别的患者与无生物标志物的患者，两者的临床缓解分别是47%与27%。而生物标志物的应用并非一帆风顺，但在不断研究中也给临床进展不顺的项目带来了希望。索元生物2017年从BMS引入治疗难治性抑郁症的DB104后，历经3年至2020年才发现生物标志物DGM4。在DGM4阳性的病人中，DB104的抗抑郁效果极为显著。用于治疗重度抑郁症（MDD）的zelquistinel同样充满波折，产品最初由Naurex发现，后辗转经过艾尔建、艾伯维，最后被Gate Neurosciences引进，目前已经完成了多项1期脑电图生物标志物研究，将在2a期临床中利用EEG生物标志物平台，深入探索产品对MDD亚群的疗效。挑战老药新用相比针对精准亚群的靶向疗法，“老药新用”研发策略是更多CNS企业选择的开发思路。事实上，很多老机制老靶点只是在临床阶段被研究多年，并未上市，只是科学研究意义上的“老”。例如KarXT中的组分xanomeline，最早于上世纪90年代开发，因不良反应被放弃，2018年才被Karuna重启与trospium组成复方制剂。包杨欢认为，未来5~8年有可能上市的新药将还是这些“老面孔”。老药新用是建立在过往几十年积累的大量试验数据和临床经验基础上，寻找有初步疗效数据的老靶点、老分子的机会。另外，鲁白教授和管小明博士共同创立的福贝生物，在与英矽智能2021年达成的AI平台合作中，也采用了老药新用策略。由英矽智能PandaOmics平台开发的FB1006，已启动IIT并完成64例患者入组。拓展阅读中国新药猎手｜遇见鲁白（上）中国新药猎手｜遇见鲁白（下）英矽智能：AI全程推动研发的样本根据普百思的统计，2019年至今，已有6款老药新用获批的CNS药物（见下表）。如，治疗产后抑郁症（PPD）的zuranolone由四氢孕酮改良而来，先改良为注射液brexanolone于2019年获批，后再制成口服制剂zuranolone于2023年批准上市。zuranolone是老药新用中微改良的典型案例。另一种常见模式是联用，受访两位专家也更看重联用方式。阿斯诺来创始人周显波谈到，老药的联用主要解决两类问题。一类是利用其中一个药物解决另一个药物的缺陷和副作用。例如被BMS收购的KarXT，是利用trospium缓解蕈毒胆碱M1/M4受体双激动剂xanomeline的毒副作用，1期临床数据显示加入trospium后确实能使药物副作用下降46%。另一款药物Axsome的Auvelity，是利用安非他酮解决右美沙芬的代谢问题，提高右美沙芬的生物利用度。阿斯诺来创始人周显波另一类是两个药物协同发挥作用。AMX0035是苯丁酸钠+牛磺酸二醇两个组分联合的老药，两款老药获批多年，因此安全性已获得验证，联合后发现产品能改善线粒体功能和内质网的健康状态、延缓神经细胞死亡，在ALS治疗中看到积极疗效，从而获得FDA批准。“联用效果更好的原因是，CNS疾病具有致病位点多、患者异质性高的特点，同时靶向多个位点的药物或者不同机制的药物联用，往往效果更好，副作用更小，复发率更低。”包杨欢如是解释。而两款老药如何在增加疗效同时减少副作用，发挥协同效果，是周显波谈到的老药新用在实际研究过程中遇到的挑战之一。例如近期AMX0035被宣布3期验证性研究失败，开发公司Amylyx表示将撤市该产品。拓展阅读Relyvrio失败对渐冻症药物试验设计的启示另一项挑战是专利问题，包括如何获取老药专利，以及联用后的新组合药物的专利保护问题。包杨欢认为，很多人把老药等同于没有专利保护，事实上国际已上市的老药新用都有一整套IP保护策略，也就是说，其他公司很难在近期简单仿制。新趋势：表型筛选目前进入临床阶段的大多数企业还是从老机制、老靶点出发，但总有企业致力于寻找新机理、新靶点，并在原始创新途中获得关注和机遇。成立于2015年的AI药物发现公司Verge Genomics，就不断获得MNC青睐：2021年与礼来达成价值近7亿美元的合作，共同开发ALS创新疗法；2023年9月，与阿斯利康的罕见疾病部门Alexion建立高达8.4亿美元的合作，寻找和验证不常见的新药物靶点。不仅如此，礼来和默克还参与了Verge近1亿美元B轮融资。吸引MNC不断加码的是Verge的ConVERGE平台，其特点是利用机器学习直接分析源于人体组织的基因组数据以发现新兴靶点，而不是动物模型数据。首个研发产品VRG50635创新性靶向PIKfyve，是治疗ALS的潜力靶点，可恢复ALS患者神经元的内溶酶体功能，并在ALS相关运动神经元变性模型中的多项临床前研究中显示出疗效，2024年1月启动了1b期概念验证研究。从Verge身上能看到，致力于新靶点的CNS药物研发还存在潜力和机遇。同时，国内的原始创新企业也在冉冉升起。国内企业中，卓凯生物的05061是全球首个抑制遗忘分子Rac1活性的阿尔茨海默症新药，通过果蝇表型筛选平台以表型筛选的方式研发而来。阿斯诺来引进的AN1001同样是通过表型筛选而来，是全球唯一口服通过肠道分布GPCR靶向迷走神经的多肽药物，2022年已在澳洲完成1期临床。据周显波介绍，AN1001是通过迷走神经脑肠轴起效，因此能避开血脑屏障阻碍，1期临床结果显示，产品已观察到脑电波量效关系的改变，安全性和生物学活性已得到初步验证。可以看到，卓凯生物和阿斯诺来药物研发的共同特点是通过表型筛选发现新药，也代表了目前CNS药物研发的新趋势。海外进展较快从已公开信息发现，在CNS新药研发应用AI并取得初步积极的临床数据方面，海外企业的进展较快。Alto Neuroscience管线中有6款产品进入临床阶段，其中ALTO-100和ALTO-300已分别在超过200名患者完成临床2a期试验，并均推进至2b期。两款均已在2a期研究中取得积极结果，以ALTO-300为例，产品给药后，通过脑电生物标志物识别出的部分患者在抑郁症状上观察到明显的临床改善和更高的缓解率。Neumora Therapeutics公司有4款产品进入临床阶段，其中治疗重度抑郁症（MDD）的NMRA-140已启动3期临床，另一项治疗精神分裂症的NMRA-266，分子机制与艾伯维收购Cerevel的潜力药物emraclidine相同，靶向新型毒蕈碱M4受体。有意思的是，这两家公司均成立于2019年，仅成立4年后已成功推动产品进入临床，且Neumora于2023年在纳斯达克上市，Alto则于近期成功登陆纽交所。产品的快速推进和IPO进度，将为其他CNS开发企业提供参考的样本。编辑 | 姚嘉yao.jia@PharmaDJ.com 总第2081期访问研发客网站可浏览更多文章www.PharmaDJ.com

临床1期

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 Zelquistinel 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
重度抑郁症	临床2期	美国	Gate Neurosciences, Inc.初创企业	2018-06-13

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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


NCT03726658 (CTgov)	临床1/2期	重度抑郁症	226	AGN-241751 (AGN-241751 3mg Daily)	範齋窪蓋願網觸壓鹹築(遞網簾簾鬱鏇衊齋願觸) = 壓壓鬱鹹憲糧願築壓選衊鑰鬱築齋襯齋膚築範 (衊窪壓鹽鹹繭糧繭壓觸, 醖蓋衊積艱顧艱鹹鹽窪 ~ 範憲醖醖膚觸衊鹽蓋襯) 更多	-	2023-07-07
				AGN-241751 (AGN-241751 10mg Daily)	範齋窪蓋願網觸壓鹹築(遞網簾簾鬱鏇衊齋願觸) = 糧壓鏇築鬱廠鏇築壓壓衊鑰鬱築齋襯齋膚築範 (衊窪壓鹽鹹繭糧繭壓觸, 壓繭齋網選齋鹽觸獵繭 ~ 艱範壓範獵鹹簾觸衊選) 更多
NCT03586427 (CTgov)	临床2期	重度抑郁症	251	AGN-241751 (AGN-241751 Dose 1)	餘夢簾觸選鹽網製願艱(淵糧衊廠築衊簾淵衊醖) = 餘醖鏇淵簾鏇鬱餘鬱積願選齋齋選壓鏇製壓網 (築醖夢壓積願遞鏇夢遞, 膚製膚鏇遞簾廠網繭鑰 ~ 襯積淵餘膚製觸遞願積) 更多	-	2022-08-02
				AGN-241751 (AGN-241751 Dose 2)	餘夢簾觸選鹽網製願艱(淵糧衊廠築衊簾淵衊醖) = 衊鑰範襯簾積範襯窪選願選齋齋選壓鏇製壓網 (築醖夢壓積願遞鏇夢遞, 艱壓願齋齋鏇網繭淵壓 ~ 獵衊憲積築襯願獵鹽襯) 更多