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
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.
数字健康 (场外交易代码：KONEF) 子公司 KGK Sciences 将推进首项评估遗传性疾病脆性X综合征（FXS）的重复口服微剂量psilocybin疗法的2a期临床试验。
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 及其客户 诺瓦门蒂斯 （OTC: NMLSF）将进行这项开创性的临床试验，研究带回家的微剂量 psilocybin 对与 FXS 相关的认知和行为症状的影响。
Wellbeing Digital received an exemption under Section 56 of the Canadian Controlled Drugs and Substances Act (CDSA).
根据《加拿大管制药物和物质法》（CDSA）第56条，Wellence Digital获得了豁免。
See Also: Section 56 (1) Exemption Takes Effect Today In British Columbia
另见：第 56 (1) 条豁免今天在不列颠哥伦比亚省生效
KGK will lead the trial and use Nova's recently completed production of API cGMP synthetic psilocybin 1.5mg microdose capsules.
KGK将领导试验，并使用Nova最近完成的API cGMP合成psilocybin 1.5mg微剂量胶囊的生产。
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.
这项由10人组成的开放标签研究的招募定于2023年第一季度开始。研究结果将用于支持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。
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.
诺瓦总裁兼首席执行官 威廉拉斯坎 表示，加拿大政府的最新监管批准是该公司研究和药物开发计划的 “关键一步”。
"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.
他补充说：“我们渴望开始招募参与者，以更好地了解psilocybin在治疗脆性X综合征中的治疗潜力。”
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，首席执行官 娜杰拉·格思里 称该临床试验是一项 “前沿” 研究，并表示该公司认为这将是 “对psilocybin在一种真正影响许多家庭生活但尚未得到研究的疾病中的潜力的有影响力的评估。”
Photo: Benzinga edit with photo by Cytonn Photography on Pexels and Jynto on Wikimedia Commons.
照片：Benzinga 在 Pexels 上编辑 Cytonn Photography 的照片，在维基共享资源上使用 Jynto 的照片。