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.
引領自閉症譜系障礙（ASD）主要遺傳病因脆性X綜合徵（FXS）的psilocybin療法的合作伙伴關係已獲得加拿大衛生部以無異議信的形式批准，並將着手進行有史以來首次針對這種疾病的神奇蘑菇療法的2a期臨床試驗。
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，心理醫療保健公司Wellebnef Digital Sciences Inc.（場外交易代碼：KONEF）的子公司KGK Sciences Inc.和總部位於加拿大的Nova Mentis Life Sciences Corp.（OTC: NMLSF）向加拿大衛生當局提交了臨床試驗申請（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.
兩家公司之間的協議意味着，從2023年初開始，長期合同研究組織KGK Sciences將進行Nova Mentis的2期臨床試驗，評估以1.5毫克膠囊形式提供的重複口服微劑量專有psilocybin療法，適用於10名FXS參與者。
"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.
“在過去的25年中，我們在KGK的團隊成功地幫助數百家公司進行了定製的臨床試驗和索賠證實策略，這些策略將產品有效地推向了全球市場。我們很高興爲我們的客戶Nova Mentis進行的這項開創性的II A期psilocybin臨床研究獲得批准。” Wellbing和KGK首席執行官納傑拉·格思裏說。
"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總裁兼首席執行官威廉·拉斯坎補充說：“Nova Mentis是世界上第一家進行人體試驗的公司，測試psilocybin對被診斷爲Fragiloxyx的成年人的療效。我們渴望收集必要的臨床數據，開發一種開創性的新療法，以幫助改善與自閉症相關的行爲和認知症狀。”
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的目標包括開發神經炎症性疾病的診斷和基於psilocybin的療法。它是第一家在美國和歐盟因使用psilocybin治療FXS而獲得孤兒藥稱號的生物技術公司。
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.
這項開放標籤研究的結果將用於支持Nova在2021年底獲得的美國食品藥品管理局孤兒藥稱號下的藥物開發計劃。
Photo courtesy of Susie Hedberg and only_kim on Shutterstock.
照片由 Susie Hedberg 和 Shutterstock 上的 only_kim 提供。