The company has been recruiting paediatric patients with ASD at Soroka Medical Center in Beersheba, Israel.
SCI-210 is a combination of cannabidiol (CBD) and CannAmide that is intended to relieve symptoms of ASD.
The randomised, double-blind and placebo-controlled trial will enrol 60 participants aged five to 18 years over a period of 20 weeks.
The study aims to compare the effects of SCI-210 with those of standard CBD treatment in managing ASD symptoms.
Its primary efficacy metrics include the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) scale, and the determination of an effective therapeutic dose.
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SciSparc designed the trial in partnership with Israel’s National Autism Research Center.
The company initially aims to introduce SCI-210 domestically in Israel, followed by launches in other countries subject to regulatory approvals.
ASD is a neurodevelopmental disorder that affects a person’s social interaction and communication skills, with a range of symptoms and severities.
SciSparc CEO Oz Adler said: “The initiation of patient recruitment for this clinical study, which has the potential to address an area of unmet medical need, marks an exciting milestone for the team at SciSparc as it aligns with our mission to improve human health through the development of novel therapies.
“We hope the outcome of the trial will enable the company to proceed with the commercialisation process for SCI-210 in Israel.”
Last year, SciSparc received approval for the trial from the Israeli Ministry of Health and the Soroka University Medical Center Ethics Committee.
Based in Tel Aviv, the company specialises in cannabinoid-based pharmaceutical technologies and assets.
Its other therapies in development include SCI-110 for Tourette syndrome, Alzheimer’s disease and agitation, as well as SCI-160 for pain management.