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Wellbeing Subsidiary KGK Science Receives Approval for First-of-its-Kind Psylocibin Clinical Trial
Wellbeing Subsidiary KGK Science Receives Approval for First-of-its-Kind Psylocibin Clinical Trial.
About this update from Wellbeing Digital Sciences Inc.
[{"type":"text","content":"\nWellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), 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, announces that its wholly owned subsidiary KGK Sciences Inc. (“KGK”), has received a No Objection letter from Health Canada, on behalf of client Nova Mentis Life Science Corp. (“Nova Mentis” or the “Client”) (CSE:NOVA, OTC:NMLSF, FRA:HN3Q) allowing KGK to proceed with the first-ever Phase II A clinical trial assessing repetitive, oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).\n\n“Our team at KGK has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies that move products efficiently into the global markets over the past 25 years. We are thrilled to receive approval for this pioneering Phase II A psilocybin clinical study for our client Nova Mentis,” commented Najla Guthrie, CEO of Wellbeing and KGK.\n\nThe results of the 10-person, open-label study will be used to support NOVA’s drug development program under FDA Orphan Drug designation, which was received in late 2021. The trial will be led by KGK Science and recruiting efforts are expected to begin in early 2023.\n\nNova Mentis has completed production of pharmaceutical grade cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used to advance the necessary research and development steps needed for successful drug regulatory approval and future commercialization.\n\n“We are thrilled to receive Health Canada approval for our pioneering psilocybin study. Nova Mentis is the first company in the world to conduct a human trial testing the efficacy of psilocybin on adults diagnosed with fragile X,” stated William Rascan, President and CEO of Nova Mentis. “We are eager to gather the necessary clinical data to develop a groundbreaking new therapy to help improve the behavioural and cognitive symptoms associated with autism.”\n\nABOUT KGK SCIENCE\n\nSubsidiary of Wellbeing Digital Sciences, KGK is a leading North American cont...