SciSparc to Commence Its Clinical Trial with SCI-210 in Children with Autism Spectrum Disorder

Exploring the Efficacy of SCI-210: SciSparc Initiates Groundbreaking Clinical Trial for Children with Autism Spectrum Disorder

SciSparc Ltd., a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system,announced it has been granted an approval from the Israeli Medical Cannabis Agency ("IMCA") at the Israeli Ministry of Health to conduct its clinical trial for SCI-210 in children suffering from autism spectrum disorder ("ASD"). SCI-210 is a proprietary combination of cannabidiol (“CBD”) and CannAmide.

With this approval, the Company has secured all necessary approvals to commence the clinical trial in Israel, including approvals from the Soroka University Medical Center Ethics Committee and Israeli Ministry of Health. The Company's goal is to sell SCI-210 first in Israel and then in various regions of the world subject to obtaining appropriate regulatory approvals.

"The initiation of this clinical trial represents a significant step forward for our proprietary SCI-210 as we work to develop a novel treatment for children and adolescents with ASD. Given there are very few safe and effective treatments for reducing ASD symptoms, we believe that SCI-210 potentially introduces a safe and effective solution to this condition, which represents a clear unmet medical need,” said SciSparc’s Chief Executive Officer, Oz Adler. “We hope the outcome of the trial  will enable the Company to procced with commercialization process for SCI-210 in Israel."

“Medical cannabis is an important field in the medical aspects," said Yuval Landsheft, Director of the IMCA at the Israeli Ministry of Health. “The IMCA was established when it was clear that professionalism is required in this field. We are in the world of pharma, and as such, we encourage companies to conduct well designed and controlled clinical trials in order to be able to approve indications and to keep Israel as a global leader in the medical cannabis,” Magister Landsheft continued.

The trial will investigate the effect and safety of SciSparc’s drug candidate SCI-210, in comparison to CBD monotherapy in treating ASD. The study's objectives are to evaluate the safety, tolerability and efficacy of SCI-210 in children with ASD in a randomized, double-blind, placebo controlled with cross-over study. The design of the study includes a 20-week, randomized double-blind placebo-controlled with cross-over clinical trial of 60 children. The trial has three primary efficacy end points: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician; and the effective therapeutic dose. The trial was designed in consultation with the National Autism Research Center, the leading research center for autism in Israel.

ASD is a condition related to brain development that impacts how a person perceives and socializes with others, causing problems in social interaction and communication. The term "spectrum" in autism spectrum disorder refers to the wide range of symptoms and severity.

Published on : 17th July, 2023