Nova Mentis Life Science (NOVA.C) announced they have received Canadian approval for their North American autism clinical study.
They received Institutional Review Board (IRB) approval in Canada on its protocol for the Observational Study, NM101: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS) (NCT04869930). They have already received IRB approval in the US.
IRBs make sure that companies employ rigorous protocol and ethical standards. The study’s data collection and storage protocols are also compliant with the Health Insurance Portability and Accountability Act (HIPAA). As Dr. Hausman, the Chairman of Nova Mentis’ Scientific Advisory Board told me, they plan on gathering a range of biomarkers, ranging from check cells to feces, in order to examine change in people’s serotonin.
That data collection is part of NOVA’s plans to create a Data Bank, which will provide them with more data on participants in their studies. Hausman told me he believes this will help them figure out what is going with autistic children and will help with FDA approval.
“This approval expands the potential patient pool outside of the US into Canada and is a key step forward in enrollment of a diverse patient population,” stated Julia V. Perederiy , PhD, NOVA’s Lead Scientist and Principal Investigator on this study. “This approval further validates our high standards of ethical and clinical practice and will help accelerate achievement of NOVA’s goal to establish baseline clinical biomarkers in children and adults with the diagnosis of ASD and/or FXS. These biomarkers will be used to validate treatment responses in an upcoming psilocybin clinical study.”
Nova Mentis is aiming to recruit 300 participants (200 with ASD or FSX, 100 neurotypical) across Canada and the US for a large-scale observational study to assess the gut microbiome, immune response, and serotonin activity. Participants will be asked to provide samples of cheek cells, urine, finger/toe-prick blood, and feces, which will be used to quantify serotonin levels. 95% percent of serotonin is produced in the small intestine, so getting biomarkers from that area through feces is crucial.
Nova Mentis’ eventual goal is to use psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, and they specifically focus on autism.
Following today’s news, their share price did not move.