The trial involves 60 individuals of five to 18 years of age with autism spectrum disorder. Credit: illustrissima / Shutterstock.

Israeli Medical Cannabis Agency (IMCA) at the Ministry of Health has renewed SciSparc’s clinical trial of SCI-210 aimed at treating paediatric patients with autism spectrum disorder (ASD).

This renewal is critical for the continuation of the study while adhering to the regulatory standards of IMCA.

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Valid for 30 days, the approval is expected to be extended following the anticipated final consent from the Israeli police department. It will allow the company to progress with its randomised, placebo-controlled, and double-blind study at Soroka University Medical Center.

In January 2023, the company and Soroka University Medical Center entered into a collaborative agreement for the SCI-210 trial.

Involving 60 individuals five to 18 years of age, the trial aims to assess the safety and efficacy of the therapy, which is a blend of cannabidiol (CBD) and CannAmide, against standard CBD monotherapy.

Subjects in the study are set to undergo a 20-week treatment programme, with the primary efficacy metrics being the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) scale, as well as determining the effective dose of the therapy.

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The trial’s design, developed in consultation with Israel’s National Autism Research Center, claims to produce significant data to improve the treatment options for this condition.

The company’s strategy includes commercialising the therapy in the Israeli market, followed by international expansion, subject to obtaining regulatory approvals.

As an Israel-based speciality clinical-stage pharmaceutical company, SciSparc is focused on developing a portfolio of cannabinoid pharmaceutical technologies and assets.

Its drug development programmes include SCI-110 for Tourette syndrome, Alzheimer’s disease, and agitation, as well as SCI-210 for autism and status epilepticus.

Last October, the company received approval from the US Food and Drug Administration to commence the trial of SCI-110 for Tourette syndrome in adults.