Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) revealed that its wholly owned subsidiary KGK Sciences Inc has received institutional review board (IRB) approval in Canada, on behalf of its client Nova Mentis Life Science Corp.
The approval allows KGK to begin its human study testing the efficacy of psilocybin on adults diagnosed with Fragile X Syndrome (FXS), the leading genetic cause of autism spectrum disorder.
Fragile X Syndrome is a genetic disorder which is caused by changes in a gene called Fragile X Messenger Ribonucleoprotein 1 (FMR1). Fragile X syndrome causes mild to severe intellectual disability.
“KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial,” Najla Guthrie, the CEO of Wellbeing and KGK, said in a statement.
“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 and that has not yet been studied. We look forward contributing to the science and alongside Nova Mentis.”
KGK Science and Nova Mentis have partnered to conduct a pioneering first clinical trial to investigate the effects of microdose psilocybin therapy on the cognitive and autism behaviour spectrum symptoms associated with Fragile X Syndrome.
The Vancouver-based company said that the results of the 10-person, open-label study will be used to support Nova’s drug development program under FDA Orphan Drug designation, which was received in late 2021. The trial will be led by KGK Science and recruiting efforts are expected to begin this year, said the firm.
The clinical trial received a no objection letter from Health Canada in December of 2023 and is one of the first approved studies that will permit participants to take home the drug for dosing every other day. In addition, the company received a section 56 exemption in February of this year, enabling an approved medical professional to prescribe select controlled substances without legal consequence, in order to better treat people with otherwise treatment-resistant conditions.
“Our team has been methodically achieving the necessary approvals and clinical planning to initiate this important study that supports Nova’s mission to improve the quality of life for people with autism and fragile X,” said Dr Marvin S Hausman, chairman of the Scientific Advisory Board at Nova Mentis.
“This approval further validates our high standards of ethical and clinical practice and is a significant clinical milestone for this study.”
Wellbeing is an evidence-based mental healthcare company focused on the development of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics. It is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trial services to clients pursuing drug development.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive