- Nova Mentis Life Science Corp. (NOVA) has submitted the Phase II A psilocybin clinical trial application to Health Canada
- It is 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)
- Fragile X syndrome (FXS) is the leading genetic cause of autism spectrum disorder (ASD)
- Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and leader in developing diagnostics and psilocybin-based therapeutics for neuro-inflammatory disorders
- Nova Mentis Life Sciences Corp. was unchanged at $0.025 at 12:05 ET
Nova Mentis Life Science Corp. (NOVA) has submitted the Phase II A psilocybin clinical trial application to Health Canada.
It is 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).
Fragile X syndrome (FXS) is 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,” said 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,” he added.
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. These cGMP synthetic psilocybin 1.5 mg microdose capsules will be used to advance the necessary research and development steps required for successful drug regulatory approval and future commercialization.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and leader in developing diagnostics and psilocybin-based therapeutics for neuro-inflammatory disorders.
Nova Mentis Life Sciences Corp. was unchanged at $0.025 at 12:05 ET.
