Health Canada Grants Exemption: Phase 2 Trial On Psilocybin For Genetic Disorder
Health Canada Grants Exemption: Phase 2 Trial On Psilocybin For Genetic Disorder
See Also: Section 56 (1) Exemption Takes Effect Today In British ColumbiaWellbeing 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.
健康數碼 (OTC: 科尼夫) 子公司 KGK 科學 將推進有史以來第一次 2a 期臨床試驗，評估重複的口服微劑量裸蓋菇鹼治療脆性 X 綜合徵（FXS），這是一種遺傳性疾病。
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 新星芒蒂斯 OTC: NMLSF）將進行這項開創性的臨床試驗，以研究帶回家微劑量裸蓋菇鹼對與 FXS 相關的認知和行為症狀的影響。
Wellbeing Digital received an exemption under Section 56 of the Canadian Controlled Drugs and Substances Act (CDSA).
健康數字公司根據《加拿大管制藥物和物質法》（CDSA）第 56 條獲得豁免。
See Also: Section 56 (1) Exemption Takes Effect Today In British Columbia
另請參閱：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，並使用諾娃最近完成的 API cGMP 合成裸蓋菇鹼 1.5 毫克微劑量膠囊的生產。
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 10 人的開放式標籤研究將於 2023 年第一季展開招聘。結果將用於支持 Nova 在 2021 年底收到的 FDA 孤兒藥物指定下的藥物開發計劃。
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.
諾瓦總裁兼執行長 威廉·拉斯 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中的「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，因為我們尋求更好地了解裸蓋菇鹼在治療脆弱 X 綜合徵方面的治療潛力。」
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."
首席執行官 KGK 代表 KGK 纳杰拉·格思里 將臨床試驗稱為「前沿」研究，該公司認為這將是「對裸蓋菇鹼的潛力進行有影響力的評估，這種疾病真正影響許多家庭的生活，尚未研究。」
Photo: Benzinga edit with photo by Cytonn Photography on Pexels and Jynto on Wikimedia Commons.
照片：使用 Cytonn 攝影在維基共享資源上的 Pexels 和 Jynto 的照片編輯。
譯文內容由第三人軟體翻譯。
