Canadian-based psychedelics company Nova Mentis Life Science Corp. NMLSF, or NOVA, is collaborating with the Toronto Institute of Pharmaceutical Technology (TIPT), a Health Canada-licensed GMP manufacturing and testing facility, to complete the production of an engineering quantity of psilocybin microdose capsules.
The partners are moving forward with the release testing stage in order to generate data required by Canada’s application process towards advancing a Phase IIa clinical trial on psilocybin microdose therapy for Fragile X Syndrome (FXS), the leading genetic cause of Autism Spectrum Disorder (ASD).
The company has partnered with contract research organization KGK Science Inc. to develop its psilocybin drug portfolio by jointly submitting the Health Canada clinical trial application.
NOVA’s work focuses on developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders and debilitating chronic conditions.
The company achieved orphan drug designation in both the US and the European Union for the use of psilocybin for the treatment of FXS. Following drug approval, NOVA has manufactured a large supply of >98% pure psilocybin for clinical studies and commercialization.
Recent preclinical research showed that a very low microdose formulation of NOVA’s psilocybin compound NM-1001 significantly modulated behavioral and cognitive defects in a genetic model of FXS.
Photo by Robina Weermeijer on Unsplash
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