Autism spectrum disorder (ASD) is the fastest growing developmental disability in the world, increasing at a rate of 10-17% each year.
According to the U.S. Centers for Disease Control and Prevention (CDC), one in 44 people in the United States has been identified with ASD. And, the costs associated with this are staggering. The global ASD therapeutics market is forecasted to be more than $5 billion by 2028 and the estimated lifetime cost of supporting a person with ASD can reach as high as $4.7 million each year.
Despite these efforts, many families are struggling to find therapeutic solutions that actually work. They are searching for new options to help improve the cognitive and behavioural symptoms associated with the disorder.
Nova’s mission is simple: improve the quality of life for people with autism and fragile x syndrome (FXS), the leading genetic cause of ASD.
Our solution is to unlock the science of synthetic psilocybin using a classic drug development approach. And, validate behavioural testing with state-of-the-art diagnostic and therapeutic technology, and deep learning artificial intelligence.
So, why is psilocybin important in autism?
Psilocybin is a serotonin agonist and activates the serotonin receptor 5-HT2A. We know that serotonin levels are much lower in ASD and FXS children and they miss key peak levels needed for normal brain development.
We believe that serotonergic insufficiency during childhood may have a compounding effect on brain patterning in ASD and FXS, manifesting as behavioural and emotional symptoms. Psilocybin is expected to mimic serotonergic signaling when innate serotonin synthesis is low, as is common in developmental delay.
In December 2022, Nova received the go-ahead to conduct the first-ever Health Canada Phase IIA clinical study assessing oral microdose psilocybin therapy for FXS.
Nova and our partner KGK Science will soon begin recruiting for the study and our objective is to demonstrate the therapeutic benefits of repetitive low-dose psilocybin in adults with FXS utilizing industry-accepted diagnostic screening tools to measure behaviour and communication.
We believe that microdosing could provide similar benefits as full-dose interventions with less risk of adverse reactions and without the hallucinogenic effects experienced with higher doses.
Nova’s preclinical research substantiates the therapeutic potential of microdosing by demonstrating that a repetitive low-dose of psilocybin significantly modulated behavioural and cognitive defects in a genetic model of FXS.
We are excited to kick off this pioneering study and are proud to be first company in the world to conduct a human trial testing the efficacy of psilocybin on adults diagnosed with FXS.