When it comes to autism spectrum disorder (ASD), the treatments available are coming up short. The pharmaceutical therapies on the market only work for some patients and come with unwanted potential side effects such as obesity and altered hormone production. Behavioral therapies can help, but can be intensive, long-term and costly. Behavioral therapies alone can cost $17,000 to $100,000 per year, depending on the severity of the ASD and the type of insurance the family has.
At last check, ASD, which has no cure, affects more than five million people in the U.S. and over 75 million worldwide, witnessing a quadruple increase in the decade to 2020. Today, ASD can be found in one in 36 children. The cost of caring for someone with ASD is projected to hit $461 billion by 2025, up 72% from $268 billion in 2015. It also takes a toll on the family. One study found families with an autistic member experience more health problems and lower overall family well-being.
Cannabis To The Rescue?
One area that holds promise in treating ASD is the use of cannabis, specifically cannabidiol (CBD). Cannabidiol (CBD) is found in hemp and cannabis sativa plants. When consumed orally or applied topically, it helps regulate mood, immune functions and pain. Research has shown it can also help alleviate many of the systems of ASD. As a result, CBD is being embraced by families of autistic children around the world, with one study reporting that 22.6% of parents use CBD for their ASD child. Annual spending is more than $1.85 billion a year. While cannabis products can reduce the number and intensity of symptoms, it too has shortcomings. Adverse side effects such as sleep disorders, restlessness and nervousness have been reported.
Greater Cannabis Company, Inc. (OTCPK: GCAN) – also known as GCANRx – the publicly traded biopharmaceutical company based in Baltimore, is all in with cannabis to treat ASD but with a twist. The company combines CBD with two proprietary compounds, which it says leads to more effective treatments without all the side effects. The novel neuropsychiatric cannabinoid therapy, which is in preclinical trials, targets several dysfunctions found in the brain that cause ASD. Those brain abnormalities are also common in schizophrenia, obsessive-compulsive disorder and general anxiety disorders. That means GCANRx may be able to treat other brain problems with its therapy. With GCANRx's therapy, the company says it improves and in some cases even reverses those dysfunctions.
Strong Pedigree Backing The Company
GCANRx's novel neuropsychiatric cannabinoid therapy is based on the work of its chief scientific advisor, Dr. Adi Aran. The certified pediatrics neurology sub-specialist is a trailblazer in researching the medical cannabis effects on autism, conducting studies dating back to 2017. Through his work, he has shown giving autistic patients CBD oil improved disruptive behaviors. A subsequent study of 60 children with ASD and severe behavior disturbances found that 61% improved behavioral outbursts, 41% improved communications, 39% reduced anxiety and 29% improved disruptive behaviors. Aran and GCANRx have a shared goal of bringing to market novel products that are more efficacious and have superior safety profiles than existing treatment options.
Trials Underway
Earlier this year GCANRx completed the preclinical phase of assessing the impact its therapy has in various combinations of the neuroprotective therapeutic. The study's in vitro data demonstrated neuroprotective attributes by both cannabidiol (CBD) and the proprietary compounds used in the therapeutic, the company reports. It is the first step in validating its cannabinoid-based therapeutic.
"These results carry promise for novel treatments for autism, as well as for other neuropsychiatric disorders such as schizophrenia, Alzheimer’s disease, and Parkinson's disease, which share similar pathophysiological processes," said Aitan Zacharin, GCANRx CEO.
Next up is a phase 2 clinical trial, which will assess the safety and efficacy of its therapeutic in pediatric patients (between four and 13 years of age) using a daily oral treatment. The patients will be randomized in a 1:1 ratio to receive either GCANRx's therapeutic or a matched placebo. GCANRx said it will begin enrolling patients in the coming weeks.
Cases of autism in the U.S. are increasing all too fast, yet the medicines and treatments aren't keeping up. GCANRx is aiming to change that with its cannabis therapeutic that combines CBD and two proprietary compounds. GCANRx is betting it will positively alter the lives of children and their families living with autism. If its clinical trial goes well, the same could potentially be said of its investors.
Featured photo by Annie Spratt on Unsplash.
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