VANCOUVER – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders  announced that it has begun recruiting participants into the first-ever clinical trial investigating the effects of psilocybin on the cognitive and behavioral symptoms associated 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’s 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.

“After achieving very positive results in NOVA’s preclinical research, we are eager to begin testing our microdose psilocybin formulation on adult patients diagnosed with fragile X syndrome. Autism is the fastest growing developmental disability in the world and we believe psilocybin therapy has the potential to provide new treatment options for the symptoms associated with this unmet medical need,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board.

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 microdose psilocybin therapy for FXS. The Company intends to confirm changes in behavioural symptoms with state-of-the-art diagnostic and therapeutic mRNA and serotonin biomarker technology, combined with machine learning artificial intelligence (AI).

NOVA has completed production of pharmaceutical grade cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used in the study.

The Company anticipates treating their first participant in Q2 2023 and having preliminary results ready later this year.

Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. 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 fragile X syndrome (FXS).

NOVA’s goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

A subsidiary of Wellbeing Digital Sciences, KGK Science is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database, and collected 10 million data points.

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