Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) Inc said its subsidiary KGK Sciences Inc has completed the chemistry, manufacturing, and controls (CMC) package to be used in support of a Phase 2A clinical trial on microdose psilocybin and fragile X syndrome for client Nova Mentis Life Science Corp.
The company said Nova has produced 1.5 mg psilocybin microdose capsules in accordance with defined manufacturing processes and product specifications as outlined in CMC published guidelines.
The package, which will be submitted to Health Canada for approval, includes a Phase 2 manufacturing process file for the psilocybin active pharmaceutical ingredient; finished product batch manufacturing records that confirm the final capsule batch has been produced; and psilocybin capsule dissolution parameters that meet regulatory requirements.
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“This is certainly an exciting time for KGK Science and our client as we finalize the clinical trial application that will be submitted to Health Canada for approval of a Phase 2A study evaluation psilocybin microdose therapy for fragile X syndrome, the leading cause of autism spectrum disorder (ASD),” commented Wellbeing CEO Najla Guthrie.
Nova Mentis CEO Will Rascan added that Nova was pleased to be working with KGK, a leading contract research organization offering high-quality clinical research trials and expert regulatory support, in this venture.
“Nova is excited to initiate the availability of its 1.5 mg psilocybin capsules to doctors, clinics and pharmaceutical companies in Canada for its potential therapeutic use in non-ASD clinical trials, including but not limited to diabetes, heart disease, epileptic conditions and post-traumatic stress disorder,” he said.
A subsidiary of Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF), KGK 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.
Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics as supported by clinical research.
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