Business
Wellbeing Subsidiary KGK Science Receives Exemption Under Section 56 of the Controlled Drugs and Substances Act to Begin Psilocybin Clinical Trial
Wellbeing Subsidiary KGK Science Receives Exemption Under Section 56 of the Controlled Drugs and Substances Act to Begin Psilocybin 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 an exemption under Section 56 of the Controlled Drugs and Substances Act, 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 IIA clinical trial assessing repetitive, oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).\n\n“KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial. We believe that this study 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,” commented Najla Guthrie, CEO of Wellbeing and KGK. “We look forward to working with Nova Mentis and contributing to the science.”\n\nKGK Science and Nova Mentis have partnered to conduct a pioneering first clinical trial to investigate the effects of microdose psilocybin on the cognitive and behavioural symptoms associated with fragile X syndrome. The results of the 10-person, open-label study will be used to support Nova Mentis’ 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. The clinical trial received a No Objection Letter from Health Canada in December of 2023 and is one of the first approved studies that will permit participants to take home the drug for dosing every other day.\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“Securing this latest regulatory approval from t...