Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) Inc announced that its wholly-owned KGK Science Inc subsidiary has entered into a research services agreement with Nova Mentis Life Science Corp for its phase II clinical trials for treating symptoms associated with Fragile X Syndrome.
The mental healthcare company said KGK will perform research services, including the development of the clinical trial protocol, regulatory and ethics submissions, conduct of the trial, data management and validation, statistical analysis and drafting of the final report.
“We are thrilled to be working with Nova Mentis for their planned phase II clinical trials to test the efficacy of psilocybin-based therapeutics for the treatment of behavioural and cognitive symptoms associated with Fragile X Syndrome (FXS),” CEO Najla Guthrie said in a statement.
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“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,” Guthrie added.
Wellbeing noted the results of the 10-person, open-label study will be used to support Nova Mentis’ drug development program under the US Food and Drug Administration (FDA) Orphan Drug designation, which was received in late 2021.
The company added that the clinical trial is planned to be conducted at KGK’s dedicated research facility in London, Ontario.
Wellbeing Digital 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.
A subsidiary of Wellbeing Digital, 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.
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