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 begun recruiting participants, on behalf of client Nova Mentis Life Science Corp. (“Nova Mentis” or the “Client”) (CSE:NOVA, OTC:NMLSF, FRA:HN3Q) in the first-ever clinical trial investigating the effects of psilocybin on adults diagnosed with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).
The 28-day study will test the safety and efficacy of Nova Mentis’ proprietary psilocybin drug (NM-1001) for the treatment of FXS and is one of the first Health Canada approved studies allowing participants to take home psilocybin for dosing every other day. Nova Mentis and KGK have partnered to conduct the Phase IIA clinical trial, which is being carried out at the KGK facility in London, Ontario, Canada. This 10-person, open-label study will assess repetitive, oral microdose psilocybin therapy for FXS. KGK and Nova Mentis intend to confirm changes in behavioral symptoms with state-of-the-art diagnostic and therapeutic mRNA and serotonin biomarker technology, combined with machine learning artificial intelligence (AI).
“KGK Science is eager to begin testing the efficacy of microdosing psilocybin in this cutting-edge clinical trial. Although we’ve seen the potential of psilocybin therapy being applied effectively for many health indications, we believe this Phase IIA clinical trial stands to make a significant impact 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.
The Company anticipates treating their first participant in Q2 2023 and having preliminary results ready later this year.
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To express your interest in participating in this study, please complete this eligibility questionnaire.
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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.
For further information on the Company, please visit www.novamentis.ca or email firstname.lastname@example.org.
On behalf of:
Chief Executive Officer
WELLBEING DIGITAL SCIENCES
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