“Serotonin is a key hormone that enables brain cells and other nervous system cells to communicate with each other,” said Dr. Marvin S. Hausman MD, Medical Director of FourthWall Testing. “Our newly-launched Serotonin Research Center, as well as our research partnerships with Microbiome Insights and Thermo Fisher Scientific, provides us with the ability to discover potential biologic activities that lead to development of ASD and gives us a needed handle to assess treatment response of autistic children.”

ASD’s are a diverse group of conditions characterized by some degree of difficulty with social interaction and communication. Other characteristics are atypical patterns of activities and behaviours, such as difficulty with transition from one activity to another, a focus on details and unusual reactions to sensations. In 2020, the CDC reported that approximately 1 in 54 children in the U.S. is diagnosed ASD, according to 2016 data.

“We are dedicated to developing treatments for people with ASD,” said Lisa Wilson, co-founder of Epitome Risk. FourthWall is a subsidiary of Epitome Risk. “As a mother, the health and safety of children and the accuracy of our lab’s study is our number one priority. We are so delighted to partner with NOVA on this critical unmet medical need.”

FourthWall and NOVA’s neuroinflammatory research program is based on identifying biomarkers that can be used to confirm the therapeutic efficacy of NOVA’s proprietary psilocybin-based drug portfolio.

FourthWall and NOVA intend to launch a longitudinal data bank to support large-scale studies of the microbiome, developmental disorder genetics serotonin activity levels, and behavioral metrics as they relate to ASD. An initial focal point will be an observational study of individuals diagnosed with ASD and fragile X syndrome (FXS).

The serotonin research centre also intends to analyze fecal, urine and blood samples from ASD and FXS individuals in the United States and Canada. An Institutional Review Board (IRB) approved clinical study has been launched by NOVA. A listing on ClinicalTrials.gov and formal start of recruitment in the U.S. will begin in the coming days.

“It is NOVA’s intent to identify specific microbes that may contribute to the development of ASD,” said Dr. Hausman. “What is also most interesting is that 95 per cent of the body’s serotonin is produced by intestinal cells as well as bacteria in the human gut; only 5 per cent is produced in the brain. ”

About FourthWall Testing
A subsidiary of Epitome Risk Solutions, FourthWall Testing is a private lab led by industry experts with more than 70 years of combined experience in drug research and development, as well as risk management services for the entertainment and sporting industries.