Vancouver - Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) ('NOVA' or the 'Company'), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is pleased to announce 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.
'Our team has been methodically achieving the necessary approvals and clinical planning to initiate this important study that supports NOVA's mission to improve the quality of life for people with autism and fragile X,' stated Dr. Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board. 'This approval further validates our high standards of ethical and clinical practice and is a significant clinical milestone for this study.'
IRBs are ethics committees designed to help regulatory agencies ensure that companies employ rigorous protocol standards and adhere to strict regulations surrounding the ethical treatment of human subjects.
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 state-of-the-art diagnostic and therapeutic biomarker technology, and machine learning artificial intelligence (AI).
NOVA'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.
About Nova Mentis Life Science Corp.
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.
About KGK Science
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.
Contact:
Will Rascan
Tel: 778-819-0244
Toll Free: 1-833-542-5323
This news release contains statements that constitute 'forward-looking statements.' Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science's actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words 'expects,' 'plans,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'projects,' 'potential' and similar expressions, or that events or conditions 'will,' 'would,' 'may,' 'could' or 'should' occur.
NOVA MENTIS LIFE SCIENCE CORP. 
