Source: Nova Mentis.
  • Nova Mentis (NOVA) has received Health Canada approval for a first-of-its-kind psilocybin clinical trial
  • The phase II A clinical trial will assess repetitive, oral microdose psilocybin therapy for Fragile X Syndrome (FXS), the leading genetic cause of autism spectrum disorder
  • Recruiting efforts are expected to begin in Q1 2023
  • Nova Mentis Life Science is focused on diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders
  • Nova Mentis (NOVA) is up by 5.56 per cent, trading at $0.095 per share

Nova Mentis (NOVA) has received Health Canada approval for a first-of-its-kind psilocybin clinical trial.

The phase II A clinical trial will assess repetitive, oral microdose psilocybin therapy for Fragile X Syndrome, the leading genetic cause of autism spectrum disorder.

The company will use its pharmaceutical-grade, cGMP synthetic psilocybin 1.5 mg microdose capsules in the study.

The results of the 10-person, open-label study will support Nova’s drug development program under an FDA Orphan Drug designation, which was received in 2021 for its proprietary psilocybin drug, NM-1001.

The trial will be led by KGK Science, Nova’s clinical research organization partner, and recruiting efforts are expected to begin in Q1 2023.

Nova’s preclinical research results showed that a low microdose formulation of its psilocybin drug significantly modulated behavioural and cognitive defects in a genetic model of FXS.

“Nova is the first company in the world to conduct a human trial testing the efficacy of psilocybin on adults diagnosed with Fragile X,” stated William Rascan, President and CEO of Nova Mentis. “We are eager to gather the necessary clinical data to develop a groundbreaking new therapy to help improve the behavioural and cognitive symptoms associated with autism.”

Nova Mentis Life Science is a Canadian-based biotechnology company focused on diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders.

Nova Mentis (NOVA) is up by 5.56 per cent, trading at $0.095 per share as of 2:04 pm ET.


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