Mental healthcare company Wellbeing Digital Sciences and its subsidiary KGK Science announced today it received an exemption under Canada’s Controlled Drugs and Substances Act to begin with its partner Nova Mentis Life Science. The company says this is the first-ever Phase IIa clinical trial assessing the efficacy of repetitive, oral microdosing of psilocybin as a therapy for Fragile X syndrome. Fragile X is the leading cause of autism spectrum disorder (ASD).
“We believe that this study will be an impactful assessment of the potential of psilocybin in a disorder that truly affects the lives of many families and that has not yet been studied,” said Najla Guthrie, CEO of Wellbeing and KGK. “We look forward to working with Nova Mentis and contributing to the science.”
KGK is a contract research organization based in London, Ontario with a focus on providing clinical trial service focused on nutraceuticals and emerging healthcare products.
The two companies will conduct the trial to assess psilocybin’s effects on the cognitive and behavioral symptoms associated with fragile x syndrome leveraging the results of a 10-person open label study from 2021 greenlighted under the FDA’s Orphan Drug designation. Nova Mentis has completed production of pharmaceutical-grade cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used in the study, and recruiting will begin later this year by KGK Science.
“Securing this latest regulatory approval from the Canadian government is a critical step in Nova Mentis’ research and drug development program and allows us to begin our groundbreaking clinical trial. We are eager to begin recruiting participants as we seek to better understand the therapeutic potential of psilocybin in the treatment of Fragile X syndrome,” said William Rascan, president & CEO of Nova Mentis.
Nova Mentis, based in Vancouver, BC, is a biotechnology company that is developing psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders. Its focus is to both diagnose and treat debilitating chronic conditions with currently unmet medical needs such as ASD and Fragile X syndrome (FXS). The company is the first to receive psilocybin orphan drug status in both the U.S. and European Union.
The company is currently conducting an observational study in ASD/FXS that it hopes will allow it to establish a “diagnostic index.” They hope it can help clinicians differentiate the subtypes of ASD and FSX to aid in more accurate diagnosis and also to inform the development of new treatments.
According to Nova Mentis, the study will compare the neuroinflammatory mRNA genetic profile obtained from cheek cells across the spectrum of ASD/FXS, as well as investigate the correlation between the mRNA genetic profile, serotonergic signaling, behavioral abnormalities and symptom severity.