Nova Mentis Granted Health Canada Section 56 Exemption to Begin Psilocybin Clinical Trial
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.