Over the last thirty years, there have been an estimated two million new cases of ASD in the United States, with social costs of more than $7 trillion1. About 1 in 54 children has been identified with autism2, and although we don’t yet have definitive information about the causes, science is getting closer to understanding the intricacies of this developmental disorder.
Currently, there are no medications available that improve the core symptoms of ASD and the limited understanding of the biology of the disorder has hampered the development of such interventions.
What we do know is that decades of research have suggested a connection between serotonin and autism. Serotonin is a neurotransmitter that plays a critical role in normal brain development. It enables brain cells and other nervous system cells to communicate with each other and therefore influences a wide array of physiological, emotional, and cognitive processes.
Humans undergo a period of high brain serotonin synthesis during childhood and this developmental process is disrupted in autistic children. In ASD and fragile X syndrome (FXS), the leading genetic cause of autism, the development of the brain and gut appears to be disrupted by altered serotonergic signaling.
It is for these reasons that Nova Mentis Life Science Corp (Nova) has launched a groundbreaking serotonin autism study and established a serotonin research centre in partnership with FourthWall Testing (FourthWall). The program is designed to fill the need for accurate diagnosis and treatment of ASD and FXS by shedding light on the pathophysiology of ‘autisms’ and guiding development of innovative new therapies.
To help us better understand the disorder, we’re conducting a large-scale observational study to assess the gut microbiome, immune/inflammatory response and serotonin activity, as all these systems are likely involved in producing the variety of behavioural symptoms observed in ASD and FXS. The research will lead to the development of a set of biomarkers to help differentiate subsets of symptomatic, as well as pre-symptomatic, ASD and FXS patients – an approach that currently does not exist in clinical practice.
The scientific community is now recognizing the importance of measuring biomarkers that define ASD subgroups when conducting studies of novel treatments3. That’s because when you subgroup participants using robust, clinical and genetic biomarkers, future clinical studies can identify individuals who may be more likely to benefit from a treatment, or more likely to experience adverse effects. We believe that serotonin is an underappreciated biomarker when it comes to the reasons why autism develops and needs to be explored further.
Positive data from this study will deepen knowledge of ASD and FXS with regard to dynamic interactions between biological systems driving development of the gut and brain, and it will set the stage for future Phase 1 and Phase 2 clinical trials of proprietary psilocybin formulations produced by Nova. The clinical lab relationship with FourthWall will allow access to cutting edge diagnostic technology especially the Dynex Agility® automated Elisa-based system. Advanced robotic processing of samples with a high level of precision will greatly enhance the development of Nova’s ASD and FXS data bank.
We believe that therapeutics developed by Nova that stimulate serotonergic signaling such as psilocybin and other tryptamine derivatives, like baeocystin and Aeruginascin, offer promise as effective early childhood interventions for children at risk of ASD.
The data collected will inform further research into the potential of using psilocybin and other tryptamine derivatives to treat ASD, as well as other neuroinflammatory conditions.
About Nova Mentis Life Science Corp.Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and fragile X syndrome. For further information on the Company, please visit https://www.novamentis.ca or email firstname.lastname@example.org.
About FourthWall TestingA 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.
For more information, please visit: https://www.epitomerisk.com/fourthwall-testing/
The lifetime social cost of autism: 1990–2029: https://www.sciencedirect.com/science/article/abs/pii/S1750946719301904
Data & Statistics on Autism Spectrum Disorder: https://www.cdc.gov/ncbddd/autism/data.html
The serotonin system in autism spectrum disorder: From biomarker to animal models: https://pubmed.ncbi.nlm.nih.gov/26577932/