KGK Science, a wholly owned subsidiary of Wellbeing Digital Sciences, has secured institutional review board (IRB) approval in Canada, to commence a Phase IIA trial to assess the efficacy of psilocybin to treat adults with fragile X syndrome (FXS), the major genetic cause of autism spectrum disorder (ASD).
KGK Science received the approval on behalf of its client Nova Mentis Life Science.
As part of the trial, KGK Science and Nova will jointly evaluate the effects of microdose psilocybin on the cognitive and autism behaviour spectrum symptoms related to FXS.
The open-label trial will include ten subjects and KGK Science will lead the trial, which aims to start enrolment this year.
Data from the trial will be used to aid Nova’s drug development programme under the Food and Drug Administration (FDA) orphan drug designation, which was secured in 2021.
Previously, Health Canada provided a no objection letter to conduct the trial, which represents one of the first approved studies to allow subjects to take home the drug for dosing.
In February this year, Wellbeing obtained a section 56 exemption, which permits an approved medical professional to prescribe select controlled substances with no legal consequence to treat people with otherwise treatment-resistant conditions.
Wellbeing and KGK Science CEO Najla Guthrie said: “We believe the first-ever Phase IIA clinical trial will be an impactful assessment of the potential of psilocybin in a disorder that truly affects the lives of many families.
“We look forward contributing to the science alongside Nova Mentis.