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Nova Submits Phase II A Psilocybin Clinical Trial Application to Health Canada

Nova Submits Phase II A Psilocybin Clinical Trial Application to Health Canada

Nova向加拿大卫生部提交第二阶段裸盖菇素临床试验申请
newsfile ·  2022/11/30 08:30

Microdose Psilocybin Safety and Efficacy Clinical Study in Fragile X Syndrome

微剂量裸盖菇素治疗脆性X综合征的安全性和有效性临床研究

Vancouver, British Columbia--(Newsfile Corp. - November 30, 2022) - Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) ("NOVA" or the "Company"), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is proud to announce that the company has submitted to Health Canada the first-ever Phase II A clinical trial application (CTA) testing the safety and efficacy of oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).

温哥华,不列颠哥伦比亚省-(Newsfile Corp.-2022年11月30日)-Nova Mentis生命科学公司(CSE:NOVA)(FSE:HN3Q)(OTCQB:NMLSF)(“Nova”或“公司”),一家生物技术公司和一流的基于裸盖菇素的神经炎性疾病治疗和补充诊断领域的全球领先企业自豪地宣布,该公司已向加拿大卫生部提交了有史以来第一份第二阶段A临床试验申请(CTA),测试口服微剂量裸盖菇素治疗脆性X综合征(FXS)的安全性和有效性。FXS是导致自闭症谱系障碍(ASD)的主要遗传原因。

"NOVA's clinical trial application is a major step in the commercial development of the Company's proprietary psilocybin drug," stated Dr. Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board. "NOVA's drug development plan is to initially establish the therapeutic potential of repetitive low-dose psilocybin to adults with FXS to improve behavioural and cognitive symptoms."

Nova公司科学顾问委员会主席Marvin S.Hausman博士说:“Nova公司的临床试验应用是公司专有裸盖菇素药物商业开发的重要一步。Nova的药物开发计划是初步确定重复小剂量裸盖菇素对患有FXS的成年人的治疗潜力,以改善行为和认知症状。“

The CTA is subject to a 30-day review by Health Canada, and if approval is granted, NOVA intends to start the clinical study in early 2023. This open-label 10 patient study will also be used to support the Company's drug development program under U.S. FDA Orphan Drug designation, which was received in late 2021.

CTA需要接受加拿大卫生部为期30天的审查,如果获得批准,Nova打算在2023年初开始临床研究。这项开放标签的10名患者研究还将用于支持该公司在美国FDA孤儿药物指定下的药物开发计划,该计划于2021年底获得。

NOVA has completed the production of its pharmaceutical grade, cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used to advance the necessary research and development steps required for successful drug regulatory approval and future commercialization.

Nova公司已经完成了其制药级cGMP合成裸盖菇素1.5 mg微剂量胶囊的生产,这种胶囊将用于推进成功获得药品监管部门批准和未来商业化所需的必要研究和开发步骤。

About Nova Mentis Life Science Corp.

关于Nova Mentis生命科学公司

Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).

Nova Mentis生命科学公司是一家总部位于加拿大的生物技术公司,在开发神经炎性疾病的诊断和基于裸盖菇素的疗法方面处于全球领先地位。Nova是第一家在美国和欧盟获得使用裸盖菇素治疗脆性X综合征(FXS)的孤儿药物指定的生物技术公司。

Our goal is to diagnose and treat debilitating chronic neuroinflammatory conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

我们的目标是诊断和治疗尚未满足医疗需求的衰弱的慢性神经炎性疾病,如自闭症谱系障碍(ASD)和FXS。

For further information on the Company, please visit or email info@novamentis.ca.

欲了解更多有关公司的信息,请访问或发送电子邮件至info@novamentis.ca。

On Behalf of the Board

我谨代表董事会

Will Rascan, President & CEO
Nova Mentis Life Science Corp.

威尔·拉斯坎,总裁兼首席执行官
Nova Mentis生命科学公司

Phone: 778-819-0244
Toll Free: 1-833-542-5323

电话:778-819-0244
免费电话:1-833-542-5323

Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

推特:@novamentislsc
Instagram:@novamentislsc
脸书:@novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

加拿大证券交易所及其市场监管机构(该术语在加拿大证券交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。

This news release contains statements that constitute "forward-looking statements." Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science's actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects," "plans," "anticipates," "believes," "intends," "estimates," "projects," "potential" and similar expressions, or that events or conditions "will," "would," "may," "could" or "should" occur.

本新闻稿包含构成“前瞻性陈述”的陈述。此类前瞻性表述涉及已知和未知的风险、不确定性和其他因素,可能导致Nova Mentis生命科学公司的实际结果、业绩或成就或行业发展与此类前瞻性表述明示或暗示的预期结果、业绩或成就大不相同。前瞻性陈述是指不是历史事实的陈述,通常但并非总是由“预期”、“计划”、“预期”、“相信”、“打算”、“估计”、“项目”、“潜在”和类似的表述,或事件或条件“将”、“将”、“可能”、“可能”或“应该”发生。

To view the source version of this press release, please visit

要查看本新闻稿的源版本,请访问

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
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