Wellbeing Digital Sciences Inc (NEO:MEDI.AQN, OTCQB:KONEF) announced that its wholly-owned subsidiary KGK Sciences Inc has received a 'No Objection letter' from Health Canada, on behalf of client Nova Mentis Life Science Corp.
This will allow 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).
“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 in a statement.
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The results of the 10-person, open-label study will be used to support NOVA’s drug development program under US Food & Drug Administration (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.
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.
“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,” added 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.”
Nova Mentis Life Science 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).
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 healthcare products.
Wellbeing Digital Sciences 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.
Contact the author at jon.hopkins@proactiveinvestors.com