­ Nova Mentis Life Science Corp. announce that the company has produced 1.5 mg psilocybin microdose capsules. These capsules were produced according to defined manufacturing processes and product specifications as outlined in chemistry, manufacturing and controls (CMC) published guidelines.

NOVA has in hand a complete CMC package to be used in support of a phase 2A microdose psilocybin fragile X syndrome (FXS) clinical trial application. The package to be submitted to Health Canada for review includes: Phase 2 manufacturing process file for psilocybin active pharmaceutical ingredient (API). Finished product batch manufacturing records that confirms final capsule batch has been produced.

Psilocybin capsule dissolution parameters that meet regulatory requirements. NOVA and KGK, its clinical research organization (CRO) partner, are currently finalizing the clinical trial application that will be submitted to Health Canada for approval of a Phase 2A study evaluating psilocybin microdose therapy for FXS, the leading genetic cause of ASD.