Clinical trial of CBD in autism receives approval in Israel

A clinical trial of a CBD-based medicine in patients with autism spectrum disorder (ASD) has received approval from the Israeli Ministry of Health.

The trial will investigate the effect of pharmaceutical company SciSparc’s drug SCI-210 in treating ASD.

SCI-210 is a proprietary combination of cannabidiol (CBD) and CannAmide™, a compound that regulates endocannabinoid levels by enhancing receptor sensitivity and inhibiting their metabolism.

The announcement comes shortly after the company received approval from the Ethics Committee of The Soroka University Medical Centre in Be’er-Sheva to conduct the trial.

The trial’s objectives are to evaluate the safety, tolerability and efficacy of SCI-210 in children and adolescents with ASD in a 20-week, randomised, double-blind, cross-over clinical trial of 60 children.

The placebo-controlled trial has three primary efficacy endpoints: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) and the effective therapeutic dose.

Oz Adler, SciSparc’s chief executive officer commented: “We are pleased to achieve another important milestone that brings us one step closer toward initiation of our clinical trial in ASD.

“ASD symptoms in paediatric patients may cause a severe decrease in life quality, for parents and children.

“We believe that our unique and proprietary SCI-210 has the potential to be a new treatment to reduce irritability and other conditions associated with ASD.”

He added: “Patients today have limited treatment options while the need for such treatment rapidly grows.

“Our drug candidates potentially enable us to provide effective, safer and more tolerable treatment with fewer side effects thanks to the lower doses of cannabinoids, boosted by the combination with CannAmide™, a mission always desirable but even more so when children are the target population.”

ASD is a condition related to brain development that impacts how a person perceives and socialises with others, causing potential difficulties in social interaction and communication.

The term “spectrum” in autism spectrum disorder refers to the wide range of symptoms and severity.

The launch of the trial is pending further approvals by the Israeli Medical Cannabis Agency.

SciSparc is currently engaged in a number of other drug development programmes covering Tourette’s Syndrome, Alzheimer’s disease and pain.