CYB-003(CYB-003) - 药物靶点：5-HT2A receptor_在研适应症：重度抑郁症，酒精使用障碍_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Deuterated Psilocybin Analog、deuterated tryptamine、CYB 003

+ [1]

靶点

5-HT2A receptor

作用机制

5-HT2A receptor激动剂(5-羟色胺2A受体激动剂)

治疗领域

其他疾病

在研适应症

重度抑郁症酒精使用障碍

非在研适应症-

原研机构

Cybin, Inc.

在研机构

Cybin IRL Ltd.

Cybin, Inc.

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评突破性疗法 (美国)

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关联

3

项与 CYB-003 相关的临床试验

NCT06605105 / Not yet recruiting临床3期

A Phase III Long-Term Extension Trial with Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants with Major Depressive Disorder (EXTEND)

This is a long- term extension of the double-blind trial, APPROACH (CYB003-002). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.

开始日期2025-02-23

申办/合作机构

Cybin IRL Ltd.

[+1]

NCT06564818 / Recruiting临床3期

A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder

The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.

开始日期2024-11-01

申办/合作机构

Cybin IRL Ltd.

[+1]

NCT05385783 / Completed临床1/2期

A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Relative Bioavailability and Food Effect Cohort to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of CYB003 in Healthy Participants With and Without Major Depressive Disorder (MDD)

The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).

开始日期2022-08-02

申办/合作机构

Cybin IRL Ltd.

[+1]

100 项与 CYB-003 相关的临床结果

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100 项与 CYB-003 相关的转化医学

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100 项与 CYB-003 相关的专利（医药）

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45

项与 CYB-003 相关的文献（医药）

2019-09-01·Cell reports1区 · 生物学

Gut Microbiota-Derived Tryptophan Metabolites Modulate Inflammatory Response in Hepatocytes and Macrophages

1区 · 生物学

OA

作者: Maria Choi ; Smitha Krishnan ; Robert C. Alaniz ; Yufang Ding ; Kyongbum Lee ; Martin L. Yarmush ; Nima Saeidi ; David H. Sherr ; Arul Jayaraman ; Gautham V. Sridharan

In the originally published version of this article, Dr. Nima Saeidi′s last name was misspelled; The correct spelling is Nima Saeidi; the correction is provided here.

2010-02-05·The Journal of organic chemistry2区 · 化学

Unique Diastereoselectivity Trends in Aminyl Radical Cyclizations onto Silyl Enol Ethers

2区 · 化学

Article

作者: Zlotorzynska, Maria ; Sammis, Glenn M. ; Zhai, Huimin

The cyclization of nitrogen-centered radicals onto silyl enol ethers is an efficient method for the synthesis of polyhydroxylated alkaloids as the 2-hydroxymethylpyrrolidine core can be readily accessed from a linear precursor. During our studies on the synthesis of polyhydroxylated alkaloid CYB-3, we found that the diastereoselectivity of the cyclization was dependent on a complex combination of sterics and olefin geometry. A more thorough understanding of the factors that lead to high diastereoselectivites would greatly expand the utility of this methodology in complex natural product synthesis. We have found that cyclization diastereoselectivities of substrates with alkyl or aryl substitution were excellent regardless of olefin geometry or substitution pattern. When electronegative substituents were introduced adjacent to the silyl enol ether, only Z-silyl enol ethers provide high diastereoselectivites. Temperature, steric size of the silyl group, and sterics and electronics of the metal hydride affected the selectivity to a lesser extent.

1994-01-01·Pharmazie in unserer Zeit

Review

作者: Susilo, R

99

项与 CYB-003 相关的新闻（医药）

2024-12-04

·PRNewswire

Facet Life Sciences Named Regulatory Partner for Cybin's Neuropsychiatry Therapeutics Development Pipeline

PHOENIXVILLE, Pa., Dec. 4, 2024 /PRNewswire/ -- Facet Life Sciences, a leader in US regulatory strategy and product development solutions for the life sciences industry, has been named as the US regulatory partner for Cybin Inc. ("Cybin"), a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative treatment options to address the large unmet need for people who suffer from mental health conditions. This collaboration will support Cybin's pioneering work in next generation therapeutics, particularly for conditions like Major Depressive Disorder, Generalized Anxiety Disorder, and Central Nervous System disorders. Facet Life Sciences will leverage its extensive expertise in US regulatory submissions to guide Cybin's development programs to and through the U.S. Food and Drug Administration ("FDA") review and approval process. Cybin's work involves novel, proprietary molecules which are in advanced clinical development. Facet Life Sciences' role will encompass strategic nonclinical, CMC, clinical, and procedural regulatory development guidance, tactical regulatory, medical writing support and submission management for Cybin's key therapies, including CYB003, Cybin's proprietary deuterated psilocin program in Phase 3 development for the potential adjunctive treatment of major depressive disorder which received FDA Breakthrough Therapy Designation earlier this year. Facet Life Sciences Named Regulatory Partner for Cybin's Neuropsychiatry Therapeutics Development Pipeline Post this "We are excited to collaborate with Cybin as their regulatory partner, supporting their mission to redefine mental health treatment through innovation," said Ken VanLuvanee, Founder and CEO, Facet Life Sciences. "Cybin's approach aligns with our mission to help advance groundbreaking therapeutics while meeting the highest regulatory standards, including our desire to bring efficacious and safe therapeutics to patients suffering with various neuropsychiatric diseases." About Facet Life Sciences Facet Life Sciences provides integrated clinical, non-clinical, manufacturing, regulatory, statistics, marketing, and commercialization services to help small and mid-sized companies achieve success. Facet's team of experts have hundreds of years of combined experience making them uniquely equipped to guide companies from the bench through development, approval, and to patients in need. About Cybin Cybin is a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next generation treatment options to address the large unmet need for people who suffer from mental health conditions. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. To learn more about Cybin, visit . For media inquiries, contact: Facet Life Sciences: [email protected] Cybin: [email protected] SOURCE Facet Life Sciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

突破性疗法临床3期

2024-12-04

·Business Wire

Cybin to Participate in Water Tower Research Fireside Chat on December 11, 2024

TORONTO--( BUSINESS WIRE )-- Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“ Cybin ” or the “ Company ”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce that Doug Drysdale, Cybin’s Chief Executive Officer, and Amir Inamdar, MBBS, DNB (Psych), FFPM, Cybin’s Chief Medical Officer, will participate in the Water Tower Research Fireside Chat Series taking place on Wednesday, December 11, 2024, at 11:00 a.m. ET. The fireside chat will be hosted by Robert Sassoon, Senior Research Analyst at Water Tower Research. Covered topics will include: CYB003’s 12-month efficacy data from its Phase II study for the treatment of major depressive disorder. The initiation of the Cybin’s Phase III PARADIGM™ program, its design, enrollment process, and milestone targets. To listen to the event, please click here to register for the webcast. The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page. About Cybin Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.

临床2期临床3期

2024-11-20

·医学新视点

100%患者产生应答，疗效可维持1年，抑郁症突破性疗法添新证据

▎药明康德内容团队编辑 Cybin公司日前公布了在研疗法CYB003在2期临床试验中的12个月疗效数据。CYB003是该公司专有的氘代裸盖菇素类似物，正在开发用于辅助治疗抑郁症（MDD）。此前，CYB003已获得美国FDA授予的突破性疗法认定。 12个月的数据显示，在接受剂量为16 mg的CYB003治疗的患者队列中，共有8名参与者完成了12个月的随访，其中7名接受了两剂CYB003的治疗。在接受两剂CYB003治疗的参与者中，抑郁症状量表（MADRS）评分与基线相比的平均变化约为23分（n=7）。接受两剂治疗的参与者中，100%产生应答，并且71%在12个月时维持缓解状态（remission）。在16 mg剂量组中，作为治疗应答者（MADRS评分减少≥50%）但未达到缓解的两名参与者的MADRS评分为11分，缓解的定义为MADRS总分≤10分。 CYB003表现出优异的安全性。在12个月随访期间未报告新的不良事件，包括无自杀倾向的报告。 Cybin公司目前已经启动CYB003的3期临床试验，用于辅助治疗抑郁症。此外，该公司还拥有一系列以5-羟色胺受体为靶点的在研化合物。相关阅读轻轻一电，改善抑郁症？《自然-医学》：缓解率高出2倍之多近半数抑郁症患者停药12个月未复发！| JAMA子刊新研究抑郁症复发率高达85%！JAMA：对抗抑郁的3大关键问题患抑郁症影响记忆力？JAMA子刊最新研究揭示，两者关系可能不止如此参考资料： [1]Cybin Reports Positive Phase 2 Data for CYB003, Demonstrating Breakthrough 12-Month Efficacy in T reating Major Depressive Disorder. Retrieved November 18, 2024, from https://www.businesswire.com/news/home/20241118852918/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，传递医学新知

临床结果突破性疗法临床3期临床2期

100 项与 CYB-003 相关的药物交易

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研发状态

10 条进展最快的记录,

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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3期	美国	Cybin IRL Ltd.	2024-11-01
酒精使用障碍	临床前	加拿大	Cybin, Inc.	2023-09-18

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临床结果

适应症

分期

评价

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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


NCT05385783 (CYB003-001, Company_Website) 人工标引	临床2期	重度抑郁症	-	CYB003 16 mg	鬱艱淵獵夢構蓋選築壓(膚窪鏇鏇遞襯積壓齋繭) = 廠淵鹽鬱獵夢衊選獵憲淵憲餘艱齋衊壓鑰膚遞 (顧餘鹹範憲蓋淵遞鏇窪 ) 更多	积极	2024-11-18
				CYB003 12 mg	鬱艱淵獵夢構蓋選築壓(膚窪鏇鏇遞襯積壓齋繭) = 觸鑰壓齋廠積獵醖顧積淵憲餘艱齋衊壓鑰膚遞 (顧餘鹹範憲蓋淵遞鏇窪 ) 更多
NCT05385783 (Biospace) 人工标引	临床1/2期	重度抑郁症	-	CYB003	願遞夢鬱製顧鑰築廠醖(淵製觸夢繭糧製艱窪範) = 獵構鏇憲齋積構築襯鏇淵觸觸淵廠遞憲壓選築 (鏇獵遞廠鹽齋糧壓壓積 ) 更多	积极	2024-09-19
				Placebo	-
NCT05385783 (ACNP2023) 人工标引	临床1/2期	重度抑郁症	36	CYB003	醖積鏇鹽膚製鹽衊廠廠(餘繭範觸鹹願廠鑰鹽衊) = This resulted in a rapid statistically significant clinical improvement of large magnitude based on the MADRS scores on Day 21. 積蓋醖廠鑰齋齋膚鹽鹹 (鑰壓鑰構築鬱廠遞餘遞 ) 更多	积极	2023-12-01
NEWS 人工标引	临床2期	抑郁症	-	CYB003 12mg	蓋蓋壓窪選壓願鹹獵觸(醖選廠淵憲遞願夢蓋窪) = 齋簾鬱壓淵夢齋簾膚壓遞齋餘壓糧選憲遞鏇鹽 (簾遞醖顧艱艱選糧淵獵 ) 更多	积极	2023-12-01
				CYB003 16mg	膚網製衊製艱築鹹繭網(願遞繭簾構築網鏇齋遞) = 築鹹獵艱鹽蓋願遞糧憲遞膚鬱繭範蓋醖餘壓簾 (鹹膚鹽顧築齋遞顧遞齋 ) 更多