Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) Inc said its wholly-owned subsidiary KGK Science Inc has submitted a clinical trial application (CTA) on behalf of client Nova Mentis Life Science Corp for a phase 2a clinical trial assessing the safety and efficacy of a microdose of psilocybin in the treatment of cognitive and behavioral symptoms associated with Fragile X Syndrome (FXS).
The CTA is subject to a 30-day review by Health Canada and if approval is granted, KGK intends to start the open-label 10-patient study in early 2023, Wellbeing said in a statement.
Wellbeing CEO Najla Guthrie said this was certainly an exciting time for KGK Science and its client Nova Mentis while they awaited Health Canada’s review of this pioneering Phase 2a psilocybin microdose study.
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“Over the past 25 years, we have successfully helped hundreds of companies with custom-designed clinical trials and claim substantiation strategies that move products efficiently into the global markets,” Guthrie said.
Nova Mentis CEO William Rascan added that this study was the first human clinical study of psilocybin for FXS and it was also intended to support an orphan drug submission with both the US Food and Drug Administration and European Medicines Agency.
“We are confident that KGK’s extensive experience in high-quality clinical research trials and expert regulatory support in the space will enable us to continue to make considerable progress towards successful treatment of ASD and FXS, currently unmet medical needs,” he said.
Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research.
A subsidiary of Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF), KGK Science is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging healthcare products.
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