KGK Science and Nova Mentis Life Science will carry out a Phase 2a clinical trial testing the efficacy of psilocybin microdosing on Fragile X Syndrome.
Fragile X Syndrome is a rare disease estimated to affect around 1 in 7,000 males and 1 in 11,000 females. The genetic disorder is a result of a mutation in the FMR1 gene, which can cause conditions such as autism spectrum disorder (ASD) as well as seizures.
There is no cure for the condition, but various treatments – such as physical and behavioural therapy – can help manage symptoms.
Wellbeing Digital Sciences’ wholly owned subsidiary, KGK, has now entered into a research services agreement with Nova Mentis Life Science that will see the pair carry out the first human research investigating the potential of a microdose of psilocybin to improve behavioural and cognitive symptoms associated with Fragile X syndrome.
CEO of Wellbeing and KGK, Najla Guthrie, stated: “We are thrilled to be working with Nova Mentis for their planned Phase 2 clinical trials to test the efficacy of psilocybin-based therapeutics for the treatment of behavioural and cognitive symptoms associated with Fragile X Syndrome (FXS).
“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.”
The results of the 10-person, open-label study will be used to support Nova Mentis’ drug development programme under FDA Orphan Drug designation which was received in late 2021.
The companies have stated that, under the agreement, 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.
President and CEO of Nova Mentis, William Rascan, commented: “Nova’s planned psilocybin treatment of FXS is a major drug development milestone for our company.
“We are confident that KGK’s extensive experience in high-quality clinical research trials and expert regulatory support in the space will enable us to make considerable progress towards successful treatment of ASD and FXS, currently unmet medical needs.”
The clinical trial will be conducted at KGK’s research facility in London, Ontario, Canada.
