Nova Mentis Life Science Corp. announced it has received institutional review board (IRB) approval in Canada to begin its human study testing the efficacy of psilocybin on adults diagnosed with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD). The Phase IIA clinical trial received the go-ahead 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.

The Company plans to begin the recruitment process within the coming weeks. KGK Science and NOVA have partnered to conduct the first-ever clinical trial to investigate the effects of psilocybin on the cognitive and behavioural symptoms associated with FXS. The results of the 10-person, open-label study will assess repetitive, oral microdose psilocybin therapy for FXS.

The Company intends to validate behavioural testing with diagnostic and therapeutic biomarker technology, and machine learning artificial intelligence (AI). KGK Science's preclinical research results, which were 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.