Health Canada Grants Section 56 Exemption: Phase 2 Trial On Psilocybin For Leading Autism Cause
Health Canada Grants Section 56 Exemption: Phase 2 Trial On Psilocybin For Leading Autism Cause
Wellbeing Digital (OTC:KONEF) subsidiary KGK Sciences will advance with the first-ever Phase 2a clinical trial assessing repetitive, oral microdose psilocybin therapy for Fragile X Syndrome (FXS), a genetic disorder.
數字健康 (場外交易代碼：KONEF) 子公司 KGK Sciences 將推進首項評估遺傳性疾病脆性X綜合徵（FXS）的重複口服微劑量psilocybin療法的2a期臨床試驗。
KGK and its client Nova Mentis (OTC:NMLSF) are set to conduct this pioneering clinical trial to study the effects of take-home microdose psilocybin on the cognitive and behavioral symptoms associated with FXS.
KGK 及其客戶 諾瓦門蒂斯 （OTC: NMLSF）將進行這項開創性的臨床試驗，研究帶回家的微劑量 psilocybin 對與 FXS 相關的認知和行爲症狀的影響。
Wellbeing Digital received an exemption under Section 56 of the Canadian Controlled Drugs and Substances Act (CDSA).
根據《加拿大管制藥物和物質法》（CDSA）第56條，Wellence Digital獲得了豁免。
See Also: Section 56 (1) Exemption Takes Effect Today In British Columbia
另見：第 56 (1) 條豁免今天在不列顛哥倫比亞省生效
KGK will lead the trial and use Nova's recently completed production of API cGMP synthetic psilocybin 1.5mg microdose capsules.
KGK將領導試驗，並使用Nova最近完成的API cGMP合成psilocybin 1.5mg微劑量膠囊的生產。
Recruitment for the 10-person, open-label study is set to start in the first quarter of 2023. Results will be used to support Nova's drug development program under FDA Orphan Drug designation received in late 2021.
這項由10人組成的開放標籤研究的招募定於2023年第一季度開始。研究結果將用於支持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。
Nova president and CEO William Rascan says that the latest regulatory approval from the Canadian government is "a critical step" in the company's research and drug development program.
諾瓦總裁兼首席執行官 威廉拉斯坎 表示，加拿大政府的最新監管批准是該公司研究和藥物開發計劃的 “關鍵一步”。
"We are eager to begin recruiting participants as we seek to better understand the therapeutic potential of psilocybin in the treatment of fragile X syndrome," he added.
他補充說：“我們渴望開始招募參與者，以更好地瞭解psilocybin在治療脆性X綜合徵中的治療潛力。”
On behalf of KGK, CEO Najla Guthrie called the clinical trial a "cutting-edge" study and says the company believes it will be "an impactful assessment of the potential of psilocybin in a disorder that truly affects the lives of many families and that has not yet been studied."
代表 KGK，首席執行官 娜傑拉·格思裏 稱該臨床試驗是一項 “前沿” 研究，並表示該公司認爲這將是 “對psilocybin在一種真正影響許多家庭生活但尚未得到研究的疾病中的潛力的有影響力的評估。”
Photo: Benzinga edit with photo by Cytonn Photography on Pexels and Jynto on Wikimedia Commons.
照片：Benzinga 在 Pexels 上編輯 Cytonn Photography 的照片，在維基共享資源上使用 Jynto 的照片。