KGK Sciences Inc., a wholly owned subsidiary of mental healthcare company Wellbeing Digital Sciences Inc. has received approval for a first-of-its kind psilocybin trial for fragile X syndrome (FXS) – the leading genetic cause of autism spectrum disorder (ASD).
The No Objection letter from Health Canada allows KGK to proceed with the first-ever Phase II A clinical trial assessing repetitive, oral microdose psilocybin therapy for the condition.
Psilocybin is a psychedelic compound found in magic mushrooms.
Najla Guthrie, CEO of Wellbeing and KGK, said:
“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”
The results of the 10-person, open-label study will be used to support NOVA’s drug development programme under FDA Orphan Drug designation, which was received in late 2021.
The trial will be led by KGK Science, with recruiting efforts 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 a drug to be approved and commercialised.
William Rascan, President and CEO of Nova Mentis, said:
“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.
“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.”
KGK is a North American contract research organisation based in London, Ontario that primarily provides clinical research trials with a focus on nutraceutical and emerging healthcare products, including psychedelics.
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