Nova Mentis Life Science Corp. announced that it has completed production of psilocybin microdose capsules in collaboration with the Toronto Institute of Pharmaceutical Technology (TIPT®). TIPT and NOVA have recently completed the manufacturing of an engineering quantity of the psilocybin microdose capsules that was used to confirm product specifications for the capsule.

Production of the first stability lot followed and capsules are currently undergoing release testing this week to generate data required for a clinical trial application. NOVA is currently preparing to submit a clinical trial application to Health Canada for a Phase 2A study evaluating psilocybin microdose therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD). NOVA's recent research results showed that a very low microdose formulation of the Company's psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects in a genetic model of FXS.

NOVA is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of FXS. Furthermore, NOVA has manufactured a large supply of >98% pure psilocybin for clinical studies and commercialization following drug approval.