SciSparc Ltd. (Nasdaq: SPRC) has announced the renewal of its approval from the Israeli Medical Cannabis Agency (IMCA) to proceed with its clinical trial of SCI-210 in children diagnosed with autism spectrum disorder (ASD). This regulatory milestone allows SciSparc to continue evaluating the safety and efficacy of its proprietary drug in a randomized, double-blind, placebo-controlled study.
The trial, taking place at Soroka University Medical Center in Israel, involves 60 children aged 5 to 18 who have been diagnosed with ASD. Participants will undergo a 20-week treatment program comparing SCI-210, a combination of cannabidiol (CBD) and CannAmide™, against standard CBD monotherapy. The primary goal is to assess symptom management and therapeutic outcomes.
Trial Design and Endpoints
The study's primary efficacy metrics include the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire and the Clinical Global Impressions-Improvement (CGI-I) scale. These tools will provide quantifiable data on the therapeutic impact of SCI-210. The trial also aims to determine an effective therapeutic dose for the drug.
SCI-210: A Novel Therapeutic Approach
SCI-210 combines CBD with CannAmide™, SciSparc's novel Palmitoylethanolamide (PEA) formulation. This combination therapy approach is designed to potentially enhance therapeutic effects through synergistic interactions between the compounds. The trial is designed in consultation with Israel's National Autism Research Center.
Commercialization Strategy
SciSparc intends to first commercialize SCI-210 in the Israeli market, followed by international expansion, contingent upon regulatory approvals. This phased approach allows the company to establish a market presence before pursuing broader global opportunities.
About SciSparc Ltd.
SciSparc Ltd. is a clinical-stage pharmaceutical company focused on developing cannabinoid-based therapies for central nervous system disorders. The company's pipeline includes treatments for Tourette Syndrome, Alzheimer's disease, autism, and status epilepticus. SciSparc also owns a controlling interest in a subsidiary focused on hemp seed oil products sold on Amazon.com.
Regulatory Details
The IMCA approval has been granted for an initial period of 30 days, with an extension expected pending final approval from the Israeli police department. SciSparc has already secured necessary approvals from the Soroka University Medical Center Ethics Committee and the Israeli Ministry of Health.
