Therapix Biosciences Announces Continued Development of Autism Spectrum Disorder Treatment

Therapix Biosciences has announced the progression of its RESPECTRUM product candidate into clinical stage. The company plans to initiate a randomized, double blind placebo controlled study to evaluate the efficacy, safety and tolerability of RESPECTRUM in treating patients with Autism Spectrum Disorder (ASD). The trial objective is to assess the efficacy and safety of RESPECTRUM versus cannabidiol (CBD)-rich oil by ASD severity measurements. Patient population is expected to include autistic subjects aged five to 35, and is based on the "entourage effect" phenomenon, hence the company expects improved efficacy, safety and tolerability over CBD alone.

This announcement follows Therapix's previous release from October 2019 describing positive results obtained in its pre-clinical program. The RESPECTRUM medicinal cannabis product is a proprietary novel preparation containing non-psychoactive CBD and Cannamide™, the Company's proprietary palmitoylethanolamide (PEA) formulation. The study will be conducted under the leadership of Dr. Orit Stolar, a Pediatric Neurologist at Shamir Medical Center in Israel. Dr. Stolar established a pharmacological clinic at the Autism Center, a combined project of Shamir Medical Center and ALUT (The Israeli National Association for Children with Autism).

"Developing the RESPECTRUM formulation for patients with autism, one of the most debilitating pediatric disorders affecting approximately one in 59 children will address a critical unmet need," said Ascher Shmulewitz, MD, PhD, Therapix's Chairman and Interim CEO. "We are expecting to complete the study by the end of 2020, and hope to become the first company to have an approved botanical based product for a specific indication. RESPECTRUM is based on the entourage effect, first described by the Chairman of our Scientific Advisory Board, Prof. Raphael Mechoulam."

"As there are many patients with autism who do not respond to medical cannabis treatment or develop adverse events associated with its use I am hopeful that RESPECTRUM will be proved safe, well-tolerated and efficacious," Dr. Stolar said. "Evidence for dysregulations of the endocannabinoid system (ECS) in human ASD are emerging. A recent study demonstrated lower serum levels of N-PEA in children with ASD in comparison with age- and gender-matched neurotypical control group. This upcoming study may shed light on the importance of the "ECS tone," and the opportunity to treat ASD with lower doses of medical cannabis."

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