First-Ever Clinical Trial On Magic Mushroom Therapy For Autism's Genetic Cause Receives Approval
First-Ever Clinical Trial On Magic Mushroom Therapy For Autism's Genetic Cause Receives Approval
"Our team at KGK has successfully helped hundreds of companies with custom-designed clinical trials and claim substantiation strategies that move products efficiently into the global markets over the past 25 years. We are thrilled to receive approval for this pioneering Phase II A psilocybin clinical study for our client Nova Mentis," said Najla Guthrie, CEO of Wellbeing and KGK.The partnership leading the way on psilocybin therapy for Fragile X Syndrome (FXS), the major genetic cause of Autism Spectrum Disorder (ASD), has received approval from Health Canada in the form of a No Objection letter and is set to proceed with the first-ever Phase 2a clinical trial on the magic mushrooms therapy for this condition.
引领自闭症谱系障碍（ASD）主要遗传病因脆性X综合征（FXS）的psilocybin疗法的合作伙伴关系已获得加拿大卫生部以无异议信的形式批准，并将着手进行有史以来首次针对这种疾病的神奇蘑菇疗法的2a期临床试验。
Mental healthcare companies Wellbeing Digital Sciences Inc. (OTC:KONEF)'s subsidiary KGK Sciences Inc. and Canadian-based Nova Mentis Life Science Corp. (OTC:NMLSF) submitted the Clinical Trial Application (CTA) to the Canadian health authority this past November.
去年11月，心理医疗保健公司Wellebnef Digital Sciences Inc.（场外交易代码：KONEF）的子公司KGK Sciences Inc.和总部位于加拿大的Nova Mentis Life Sciences Corp.（OTC: NMLSF）向加拿大卫生当局提交了临床试验申请（CTA）。
The deal between both companies entails that long-standing Contract Research Organization KGK Sciences will conduct Nova Mentis' Phase 2 clinical trial assessing repetitive, oral microdose proprietary psilocybin therapy in the form of 1.5 mg capsules- for 10 participants with FXS beginning in early 2023.
两家公司之间的协议意味着，从2023年初开始，长期合同研究组织KGK Sciences将进行Nova Mentis的2期临床试验，评估以1.5毫克胶囊形式提供的重复口服微剂量专有psilocybin疗法，适用于10名FXS参与者。
"Our team at KGK has successfully helped hundreds of companies with custom-designed clinical trials and claim substantiation strategies that move products efficiently into the global markets over the past 25 years. We are thrilled to receive approval for this pioneering Phase II A psilocybin clinical study for our client Nova Mentis," said Najla Guthrie, CEO of Wellbeing and KGK.
“在过去的25年中，我们在KGK的团队成功地帮助数百家公司进行了定制的临床试验和索赔证实策略，这些策略将产品有效地推向了全球市场。我们很高兴为我们的客户Nova Mentis进行的这项开创性的II A期psilocybin临床研究获得批准。” Wellbing和KGK首席执行官纳杰拉·格思里说。
"Nova Mentis is the first company in the world to conduct a human trial testing the efficacy of psilocybin on adults diagnosed with Fragile X. We are eager to gather the necessary clinical data to develop a groundbreaking new therapy to help improve the behavioral and cognitive symptoms associated with autism," added Nova's president and CEO William Rascan.
Nova总裁兼首席执行官威廉·拉斯坎补充说：“Nova Mentis是世界上第一家进行人体试验的公司，测试psilocybin对被诊断为Fragiloxyx的成年人的疗效。我们渴望收集必要的临床数据，开发一种开创性的新疗法，以帮助改善与自闭症相关的行为和认知症状。”
Nova Mentis' goal includes developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. It is the first biotech to achieve orphan drug designation in both the US and EU for the use of psilocybin in the treatment of FXS.
Nova Mentis的目标包括开发神经炎症性疾病的诊断和基于psilocybin的疗法。它是第一家在美国和欧盟因使用psilocybin治疗FXS而获得孤儿药称号的生物技术公司。
Results from the open-label study will be used to support Nova's drug development program under FDA Orphan Drug designation, received in late 2021.
这项开放标签研究的结果将用于支持Nova在2021年底获得的美国食品药品管理局孤儿药称号下的药物开发计划。
Photo courtesy of Susie Hedberg and only_kim on Shutterstock.
照片由 Susie Hedberg 和 Shutterstock 上的 only_kim 提供。
