SciSparc Gets Renewal for Autism Clinical Trial by Israeli Cannabis Agency

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

This renewal reaffirms the Company's compliance with IMCA regulatory requirements and enables the continued progression of its clinical trial. The approval was received for a period of 30 days and will be extended pending the final approval by the Israeli police department, which is expected to be received within 30 days. SciSparc has also previously received the necessary approvals from the Soroka University Medical Center Ethics Committee and the Israeli Ministry of Health to conduct the trial, advancing its innovative treatments for ASD.

The clinical trial for SCI-210 is a double-blind, randomized, and placebo-controlled study conducted at Soroka University Medical Center in Israel, involving 60 children aged 5 to 18 with ASD. The trial aims to evaluate the efficacy and safety of SCI-210, a proprietary combination of CBD and CannAmide™ (SciSparc's novel Palmitoylethanolamide formulation), compared to standard CBD monotherapy. Participants will undergo a 20-week treatment program, focusing on symptom management and therapeutic outcomes.

The study’s 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. The Company believes that this trial, designed in consultation with Israel's National Autism Research Center, is expected to generate valuable data to advance treatment options for individuals with ASD.

With commercialization of SCI-210 planned first in the Israeli market and subsequent expansion internationally, subject to regulatory approvals, SciSparc is dedicated to offering innovative solutions that address the unmet needs of individuals with ASD and their families.

About SciSparc Ltd.

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of autism and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds’ oil-based products on the Amazon.com Marketplace.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!