Wellbeing Digital Sciences Inc. announced that its wholly owned subsidiary KGK Sciences Inc., has begun recruiting participants, on behalf of client Nova Mentis Life Science Corp. in the first-ever clinical trial investigating the effects of psilocybin on adults diagnosed with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD). The 28-day study will test the safety and efficacy of Nova Mentis' proprietary psilocybin drug (NM-1001) for the treatment of FXS and is one of the first Health Canada approved studies allowing participants to take home psilocybin for dosing every other day.

Nova Mentis and KGK have partnered to conduct the Phase IIA clinical trial, which is being carried out at the KGK facility in London, Ontario, Canada. This 10-person, open-label study will assess repetitive, oral microdose psilocybin therapy for FXS. KGK and Nova Mentis intend to confirm changes in behavioral symptoms with diagnostic and therapeutic mRNA and serotonin biomarker technology, combined with machine learning artificial intelligence (AI).

The Company anticipates treating their first participant in the second quarter of 2023 and having preliminary results ready later this year.