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
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.
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.
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.
"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.
"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 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.
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.
Photo courtesy of Susie Hedberg and only_kim on Shutterstock.
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）的主要遺傳原因脆性 X 綜合症（FXS）裸蓋菇鹼療法的合作夥伴關係已獲得加拿大衛生部的批准，並將繼續進行有關這種情況的魔術蘑菇療法的 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.
心理保健公司福利數字科學公司（OTC：KONEF）的子公司 KGK Science Inc. 和總部位於加拿大的諾瓦門蒂斯生命科學公司（OTC：NMLSF）在過去的 11 月向加拿大衛生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.
這兩家公司之間的交易需要長期合同研究組織 KGK Scienciences 將進行諾瓦門蒂斯 '階段 2 臨床試驗評估重複, 口服微劑量專有裸蓋菇鹼療法的形式 1.5 毫克膠囊-為 10 參與者與 FXS 初開始 2023.
"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.
我們在 KGK 的團隊已經成功地幫助了數百家公司進行定制的臨床試驗，並宣告了在過去 25 年中有效地將產品推向全球市場的實證策略。我們很高興能獲得這項針對我們客戶 Nova Mentis 的開創性第二期甲裸蓋菇鹼臨床研究的批准。」
"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（William RasCAN）補充道：「Nova Mentis 是世界上第一家進行人體試驗的公司，以幫助改善與自閉症相關的行為和認知症狀的成年人進行人體試驗。
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 的目標包括開發用於神經炎症性疾病的診斷和基於裸蓋菇素的治療藥物。它是第一個在美國和歐盟實現孤兒藥物名稱的生物技術，用於治療 FXS 中裸蓋菇鹼。
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.
開放標籤研究的結果將用於支持 Nova 在 FDA 孤兒藥物指定下的藥物開發計劃，該計劃於 2021 年底收到。
Photo courtesy of Susie Hedberg and only_kim on Shutterstock.
照片由蘇西·赫伯格和薩特斯托克上唯一的 KIM 提供。
譯文內容由第三人軟體翻譯。
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