The trial will evaluate SciSparc’s SCI-210 for the treatment of ASD. Credit: Caleb Woods on Unsplash.

SciSparc and the Soroka University Medical Center Israel have signed an agreement for a clinical trial of drug candidate SCI-210 in patients with autism spectrum disorder (ASD), a condition related to brain development.

Last year, SciSparc received approval from the Israeli Ministry of Health and the Ethics Committee of the Soroka University Medical Center to conduct the study.

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The clinical trial has been designed to evaluate the safety and effects of SciSparc’s SCI-210 against CBD monotherapy for the treatment of ASD.

SCI-210 is a combination of cannabidiol and CannAmide.

SciSparc CEO Oz Adler said: “The trial in ASD strengthens the company’s advanced clinical programmes, alongside our phase IIb clinical trial for SCI-110 in patients with Tourette Syndrome and the phase IIa clinical trial of SCI-110 in patients with Alzheimer’s disease and agitation.

“We are honoured to collaborate with Soroka Medical Center, a leading medical centre in Israel which co-established and is a partner of the Israeli National Centre for Autism and Neurodevelopment Research, a leading international center for innovation in translational research, diagnosis, and interventions in ASD and other neurodevelopmental conditions.”

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The objectives of the trial are to assess SCI-210’s tolerability, safety, and efficacy in children with ASD in a randomised, double-blind, placebo controlled with cross-over study.

It will be carried out in 60 children for 20 weeks.

The Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the effective therapeutic dose, and the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician are the three primary efficacy end points of the trial.

In August last year, SciSparc signed a clinical trial agreement with Yale University to add the Yale Child Study Center as a site for the Phase IIb trial of SCI-110 to treat Tourette Syndrome (TS).