Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) said its wholly-owned subsidiary KGK Sciences Inc. has received an exemption under Section 56 of the Controlled Drugs and Substances Act.
The exemption, on behalf of client Nova Mentis Life Science Corp, allows KGK to proceed with the first-ever Phase IIA clinical trial assessing repetitive, oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD), the company said.
“KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial,” Wellbeing and KGK CEO Najla Guthrie said in a statement.
READ: Wellbeing Digital Sciences says KGK subsidiary gets OK to proceed with Phase II A clinical trial assessing psilocybin therapy for fragile X syndrome
“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,” Guthrie added. “We look forward to working with Nova Mentis and contributing to the science.”
Wellbeing said KGK Science and Nova Mentis have partnered to conduct a pioneering first clinical trial to investigate the effects of microdose psilocybin on the cognitive and behavioral symptoms associated with fragile X syndrome.
The results of the 10-person, open-label study will be used to support Nova Mentis’ 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 in early 2023.
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, Wellbeing added.
The company noted that Nova Mentis has completed production of pharmaceutical grade cGMP (current good manufacturing practice) synthetic psilocybin 1.5 mg microdose capsules that will be used to advance the necessary research and development steps needed for successful drug regulatory approval and future commercialization.
“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,” Nova Mentis president and CEO William Rascan said. “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.”
KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging healthcare products.
Wellbeing is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research.
Its mission 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 at stephen.gunnion@proactiveinvestors.com