SciSparc Ltd. (NASDAQ:SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that it has received approval from the Ethics Committee of The Soroka University Medical Center, in Be'er-Sheva, Israel (the "Ethics Committee"), to conduct the Company's clinical trial for SCI-210 in patients suffering from Autism Spectrum Disorder ("ASD").
The trial will investigate the effect of the Company's drug candidate SCI-210, a proprietary combination of cannabidiol ("CBD") and CannAmide™, versus CBD monotherapy, in treating ASD.
The trial's objectives are to evaluate the safety, tolerability and efficacy of SCI-210 in children with ASD in a designed 20-week, randomized, double-blind, placebo controlled with a 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.
"We are honored to receive the Ethics Committee approval, an important step toward initiation of our clinical trial in ASD," commented Oz Adler, SciSparc's Chief Executive Officer. We believe that our unique and proprietary SCI-210 has the potential to be a new treatment to reduce irritability and other symptoms associated with ASD in pediatric patients, a condition with limited available treatments. Just a month ago we announced the Ethics Committee approval of our novel and proprietary SCI-110 for the treatment of Tourette Syndrome and today with great enthusiasm we announce the Ethic Committee's approval of our novel and proprietary SCI-210 platform. These approvals are important milestones for SciSparc and they demonstrate our commitment to change the life of millions. Our drug candidates potentially enable us to provide effective and safer treatments with fewer side effects thanks to the lower doses of active ingredients, 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 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.
The launch of the trial is pending further approvals by the Israeli Ministry of Health and the Israeli Medical Cannabis Agency.