Company Plans to Submit Clinical Trial Application in Canada
Vancouver, British Columbia— September 15, 2022 – 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 that it has completed production of psilocybin microdose capsules in collaboration with the Toronto Institute of Pharmaceutical Technology (TIPT®).
TIPT and NOVA have recently completed the manufacturing of an engineering quantity of the psilocybin microdose capsules that was used to confirm product specifications for the capsule. Production of the first stability lot followed and capsules are currently undergoing release testing this week to generate data required for a clinical trial application.
NOVA is currently preparing to submit a clinical trial application to Health Canada for a Phase 2A study evaluating psilocybin microdose therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD). NOVA’s recent research results showed that a very low microdose formulation of the Company’s psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects in a genetic model of FXS.
“A major success for NOVA to achieve this critical drug development accomplishment! Our team is incredibly dedicated and focused on achieving our planned milestones as we work towards meeting our mission of diagnosing and treating chronic conditions such as autism spectrum disorder and fragile X syndrome,” said Jacqueline McConnell, NOVA’s Chief Operating Officer.
The Company has formed a tactical partnership with KGK Science Inc. to develop its psilocybin drug portfolio in Canada. KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on the nutraceutical, cannabis and emerging psychedelic industries. Both Companies plan to jointly submit the Health Canada clinical trial application.
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 FXS. Furthermore, NOVA has manufactured a large supply of >98% pure psilocybin for clinical studies and commercialization following drug approval.
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).
Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.
The Toronto Institute of Pharmaceutical Technology (TIPT®) is North America’s premier pharmaceutical institute of education, technology and research. We operate a fully compliant Health Canada-licensed GMP manufacturing and testing facility for solid dosage forms and liquid preparations.
Since our inception in 1992, we have successfully established corporate partnerships with leading pharmaceutical companies worldwide and have provided innovative product development solutions uniquely supported by pragmatic institutional experts.
For more information, please visit: www.tipt.com.
About KGK Science
Founded in 1997, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on the nutraceutical, cannabis and emerging psychedelic industries. 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. On an approximate basis, the business to date has produced 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.
For more information, please visit: www.kgkscience.com/.
On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.