Israeli Pharmaceutical Company Announces Clinical Stage of Medical Cannabis Autism Product
Therapix Biosciences, an Israel-based pharmaceutical company focusing on cannabinoid treatments, announced that its medicinal cannabis product RESPECTRUM has entered the clinical stage. In a press release, the company said it plans to initiate a study to evaluate the effectiveness and safety of RESPECTRUM in treating patients with autism spectrum disorder (ASD). The study is expected to include participants between five and 35 years old.
“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," Dr. Ascher Shmulewitz, Therapix's Chairman and Interim CEO, said. "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."
The study will be led by Dr. Orit Stolar, a pediatric neurologist at Israel’s Shamir Medical Center.
"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."