Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) reported that its subsidiary KGK Science on behalf of its client Nova Mentis has commenced patient recruitment for its first-of-its-kind, Health Canada-approved clinical trial investigating psilocybin in adults diagnosed with fragile X syndrome (FXS).
The Phase 2a trial, being conducted at KGK’s facility in London, Ontario, will test the safety and efficacy of Nova Mentis’ psilocybin drug NM-1001 for FXS, which is a leading genetic cause of autism spectrum disorder.
It will assess repeated, oral microdose psilocybin therapy for FXS and is one of the first Health Canada-approved trials to allow participants to take home psilocybin for dosing every other day, Wellbeing highlighted.
KGK and Nova Mentis intend to use diagnostic and therapeutic mRNA and serotonin biomarker technology combined with machine learning artificial intelligence to confirm changes in the participants’ behavioural symptoms.
The first patient is expected to be treated in the second quarter of 2023, with preliminary results to follow later in the year.
“KGK Science is eager to begin testing the efficacy of microdosing psilocybin in this cutting-edge clinical trial, said Wellbeing and KGK CEO Najla Guthrie in a statement.
“Although we’ve seen the potential of psilocybin therapy being applied effectively for many health indications, we believe this Phase 2a 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.”
A subsidiary of Wellbeing, KGK is a contract research organization based in London, Ontario, that provides high-quality clinical research trials with a focus on nutraceutical and emerging healthcare products.
Wellbeing focuses on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research.
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