Nova Mentis Life Science Corp. provided an update on its Phase IIA clinical trial testing psilocybin for the treatment of fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD). The research team is continuing its recruitment efforts and has now begun prescreening a number of potential participants with a FXS diagnosis to determine if they are eligible to join the clinical trial.

Through advertising efforts across Ontario, Canada and connecting with ASD and FXS support groups, work is underway to create a registry of trial participants. The 28-day study will evaluate the safety and efficacy of NOVA's proprietary microdose psilocybin formulation on adult patients diagnosed with FXS, and is one of the first Health Canada approved studies allowing participants to take home psilocybin for dosing every other day. NOVA has completed production of pharmaceutical grade cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used in the study.

NOVA and KGK Science 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 low-dose psilocybin therapy for FXS. The Company intends to confirm changes in behavioural symptoms with diagnostic and therapeutic mRNA and serotonin biomarker technology, combined with machine learning artificial intelligence (AI).

The Company anticipates treating the 10 participants in third quarter/Q4 2023 and having preliminary results ready early in 2024.