Wellbeing Digital Sciences Inc. (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., has submitted a clinical trial application (“CTA”) on behalf of client Nova Mentis Life Science Corp. (CSE:NOVA | OTC:NMLSF | FRA:HN3Q) for a phase IIa clinical trial assessing the safety and efficacy of a microdose of psilocybin in the treatment of cognitive and behavioural symptoms associated with Fragile X Syndrome (“FXS”).
“This is certainly an exciting time for KGK Science and our client Nova Mentis as we await Health Canada’s review of this pioneering Phase IIa psilocybin microdose study. Over the past 25 years, we have successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies that move products efficiently into the global markets.”Najla Guthrie, CEO of Wellbeing Digital & KGK Science
The CTA is subject to a 30-day review by Health Canada, and if approval is granted, KGK intends to start the clinical study in early 2023. This open-label 10 patient study will also be used to support Nova Mentis’ drug development program under U.S. FDA Orphan Drug designation, which was received in late 2021.
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.
“The submission of the CTA is a significant milestone in the clinical development of Nova Mentis’ proprietary drug called NM-1001,” said William Rascan, President & CEO of Nova Mentis. “The study is the first human clinical study of psilocybin for FXS and is also intended to support an Orphan Drug submission with the both the U.S. Food and Drug Administration and European Medicines Agency. We are confident that KGK’s extensive experience in high-quality clinical research trials and expert regulatory support in the space will enable us to continue to make considerable progress towards successful treatment of ASD and FXS, currently unmet medical needs.”
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
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.