Health Canada Grants Exemption: Phase 2 Trial On Psilocybin For Genetic Disorder

Wellbeing Digital KONEF subsidiary KGK Sciences will advance with the first-ever Phase 2a clinical trial assessing repetitive, oral microdose psilocybin therapy for Fragile X Syndrome (FXS), a genetic disorder.

KGK and its client Nova Mentis NMLSF are set to conduct this pioneering clinical trial to study the effects of take-home microdose psilocybin on the cognitive and behavioral symptoms associated with FXS.

Wellbeing Digital received an exemption under Section 56 of the Canadian Controlled Drugs and Substances Act (CDSA).

See Also: Section 56 (1) Exemption Takes Effect Today In British Columbia

KGK will lead the trial and use Nova’s recently completed production of API cGMP synthetic psilocybin 1.5mg microdose capsules.

Recruitment for the 10-person, open-label study is set to start in the first quarter of 2023. Results will be used to support Nova’s drug development program under FDA Orphan Drug designation received in late 2021. 

Nova president and CEO William Rascan says that the latest regulatory approval from the Canadian government is “a critical step” in the company’s research and drug development program.

“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,” he added.

On behalf of KGK, CEO Najla Guthrie called the clinical trial a “cutting-edge” study and says the company believes it 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."

Photo: Benzinga edit with photo by Cytonn Photography on Pexels and Jynto on Wikimedia Commons.