Canadian biotech firm granted exemption to initiate phase 2 psilocybin study

Nova Mentis Life Science Corp. has received an exemption under Section 56 of the Health Canada Controlled Drugs and Substances Act to advance a phase 2a clinical trial examining oral microdose psilocybin therapy for fragile X syndrome.

According to a company release, the exemption allows approved medical professionals to legally prescribe certain controlled substances to improve care for treatment-resistant conditions.

“Securing this latest regulatory approval from the Canadian government is a critical step in Nova’s research and drug development program and allows us to begin our groundbreaking clinical trial,” William Rascan, Nova Mentis president and CEO, stated in the release. “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.”

Per the release, the clinical trial — one of the first approved studies to allow participants to take the drug home for every-other-day dosing — will be led by KGK Science. Recruitment is expected to begin late in the first quarter of 2023, with results from the 10-person, open-label study expected to bolster the company’s drug development program under orphan drug designation, which was granted by the FDA in late 2021.

“KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial,” Najla Guthrie, CEO of Wellbeing and KGK, said in the release. “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.”

Nova also stated it has completed production of pharmaceutical grade synthetic psilocybin in 1.5-mg capsules, which will further research and development steps needed for future regulatory approval and commercialization.