The Company has obtained Institutional Review Board (IRB) approval in Canada of its protocol for the Observational Study, NM101: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS) (NCT04869930). The study received IRB approval in the United States earlier this year.
“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.”
IRBs are ethics committees designed to help regulatory agencies ensure that companies employ rigorous protocol standards and adhere to strict regulations surrounding the ethical treatment of human subjects. The study’s data collection and storage protocols are also compliant under the Health Insurance Portability and Accountability Act (HIPAA), which sets the standard for protection of sensitive patient data.
NOVA aims to recruit at least 300 participants across the U.S and Canada for its large-scale observational study to assess the gut microbiome, immune response, and serotonin activity, as all these systems are likely involved in producing the variety of gut and behavioural symptoms observed in ASD and FXS.
The Company will recruit 200+ participants with diagnosed ASD or FXS and 100+ neurotypical controls, including pre-symptomatic/undiagnosed children under age five. 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 and related cell signaling pathways, as well as evaluate commensal bacterial species and their function in the gut. Samples will be compared with those from age-matched neurotypical controls.