Nova Submits Phase II A Psilocybin Clinical Trial Application to Health Canada
Microdose Psilocybin Safety and Efficacy Clinical Study in Fragile X Syndrome
Vancouver, British Columbia--(Newsfile Corp. - November 30, 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 proud to announce that the company has submitted to Health Canada the first-ever Phase II A clinical trial application (CTA) testing the safety and efficacy of oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).
"NOVA's clinical trial application is a major step in the commercial development of the Company's proprietary psilocybin drug," stated Dr. Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board. "NOVA's drug development plan is to initially establish the therapeutic potential of repetitive low-dose psilocybin to adults with FXS to improve behavioural and cognitive symptoms."
The CTA is subject to a 30-day review by Health Canada, and if approval is granted, NOVA intends to start the clinical study in early 2023. This open-label 10 patient study will also be used to support the Company's drug development program under U.S. FDA Orphan Drug designation, which was received in late 2021.
NOVA has completed the production of its pharmaceutical grade, cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used to advance the necessary research and development steps required for successful drug regulatory approval and future commercialization.
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 neuroinflammatory conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.
On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.
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