Completion of THX-110 trial marks a step forward for medical cannabis development

23rd April 2018 (Last Updated April 23rd, 2018 12:09)

Therapix Biosciences, a biopharmaceutical company focused on the development of cannabinoid-based treatments, reported topline data on April 9th from a Phase IIa study at Yale University showing that its cannabinoid-based treatment, THX-110, met its primary endpoint for Tourette syndrome (TS). THX-110, which is a combination drug of dronabinol (THC) and palmitoylethanolamide (PEA), significantly improved symptoms in adult subjects with the disorder.

Therapix Biosciences, a biopharmaceutical company focused on the development of cannabinoid-based treatments, reported topline data on April 9th from a Phase IIa study at Yale University showing that its cannabinoid-based treatment, THX-110, met its primary endpoint for Tourette syndrome (TS). THX-110, which is a combination drug of dronabinol (THC) and palmitoylethanolamide (PEA), significantly improved symptoms in adult subjects with the disorder.

TS is a neurological disorder characterised by multiple motor and vocal tics that usually starts during childhood and is often accompanied by behavioral symptoms. According to the National Survey on Children’s Health, published in 2011, one out of every 360 children in the US has been diagnosed with TS, and about 35,000 children have moderate or severe TS. There is no cure for Tourette's syndrome, but treatment can help patients manage the symptoms.

Cannabinoids have been used for hundreds of years for medical purposes such as pain reduction, anti-inflammation, and reduction or prevention of nausea. In TS, several studies have provided evidence that marijuana might be effective not only in the suppression of tics, but also in the treatment of associated behavioral problems.

The Phase IIa study was a single-arm, open-label trial, studying a single daily administration of THX-110 for 12 weeks. The study was conducted in 16 subjects at the Yale University Child Study Center, US, where the results showed that all 16 subjects with TS had a reduction of tic symptoms. However, further placebo-controlled trials are needed to demonstrate THX-110’s efficacy. A Phase IIb, placebo-controlled trial will start in Q2 2018 at Hannover Medical School, and will last approximately one year.

The Israeli company, which is based in Tel Aviv, is seeking orphan drug designation for its compound and is also working to use THX-110 for several other indications besides TS, such as pain management, obstructive sleep apnea (OSA), and traumatic brain injury.

Development of cannabinoid-based treatments

Cannabis is a fast-growing sector. Every year, new products are commercialised to fill this market and new areas of the world open up to licensed cannabis use. There is a large pipeline of cannabinoid-based products currently in development, with the vast majority (around 82%) of pipeline products being in the early stages of development. While there are large areas of possible indications currently being researched, a common disease being investigated with cannabinoid-based products is resistant or refractory pediatric epilepsies.

GW Pharmaceuticals is one of the main companies developing cannabinoid-based medicines. One such product is Epidiolex, a liquid formulation of cannabidiol, which is under review by FDA for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome.

FDA approval would technically limit the therapy to a small group of epilepsy patients, but physicians would have the option to prescribe it for other uses and it could bring new interest and pharmaceutical research into cannabis-based products. According to GlobalData’s report, PharmaPoint: Epilepsy – Global Drug Forecast and Market Analysis to 2026, Epidiolex is forecast to reach $1.2B in sales in 2026, largely due to its expected high annual cost of therapy, further reinforcing the large commercial potential of cannabinoid-based therapies.

The cannabis market is growing in both power and profitability, and is evolving into a multibillion-dollar legal industry, which is an impressive feat considering its almost global illegality 20 years ago. GlobalData believes that the efficacy demonstrated in these studies further reinforces the potential role of cannabinoids for research and treatment for central nervous system (CNS) disorders.

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