Nova Mentis Life Science Corp. announced that the company has received a No Objection Letter from Health Canada, allowing NOVA to proceed with the first-ever Phase II A clinical trial assessing repetitive, oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD). 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, NOVA's clinical research organization (CRO) partner, and recruiting efforts are expected to begin first quarter 2023. In September, NOVA completed production of pharmaceutical grade, cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used in the study as the Company advances the necessary research and development steps required for successful drug regulatory approval and future commercialization. NOVA's preclinical research results, which were recently published in an international science journal, showed that a low microdose formulation of the Company's psilocybin drug significantly modulated behavioural and cognitive defects in a genetic model of FXS.