A section 56 exemption can enable an approved medical professional to prescribe select controlled substances without legal consequence, in order to better treat people with otherwise treatment-resistant conditions.
VANCOUVER, British Columbia--Wellbeing 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).
“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.”
KGK 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.
Nova 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.
“Securing this latest regulatory approval from the Canadian government is a critical step in Nova Mentis’ research and drug development program and allows us to begin our groundbreaking clinical trial. 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,” stated William Rascan, President & CEO of Nova Mentis.
ABOUT KGK SCIENCE
Subsidiary of Wellbeing Digital Sciences, 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 health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com.
ABOUT WELLBEING DIGITAL SCIENCES
Wellbeing Digital Sciences Inc. 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. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. For additional information, please visit wellbeingdigital.co.
ABOUT NOVA MENTIS
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).
Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.
On behalf of:
Chief Executive Officer
WELLBEING DIGITAL SCIENCES
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