Nova Mentis Life Science Corp. announced it has received an exemption under Section 56 of the Controlled Drugs and Substances Act allowing the Company 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). A Section 56 exemption enables an approved medical professional to prescribe select controlled
substances without legal consequence, in order to better treat people with otherwise treatment-resistant conditions. KGK Science and NOVA have partnered to conduct a pioneering first clinical trial to investigate the effects of microdose psilocybin on the cognitive and behavioural symptoms associated with FXS. 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 in late First Quarter 2023. The clinical trial received a No Objection Letter from Health Canada in December of 2022 and is one of the first approved studies that will permit participants to take home the drug for dosing every other day. Nova Mentis has completed production of pharmaceutical grade cGMP 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.