SciSparc Enrolls First Five Patients in SCI-210 Clinical Trial

SciSparc Ltd. (Nasdaq: SPRC), a clinical-stage pharmaceutical company focused on central nervous system therapies, has announced significant progress in its clinical trial for children with autism spectrum disorder (ASD). The trial is being conducted at the Soroka Medical Center in Israel and aims to evaluate the efficacy of SciSparc's proprietary medication, SCI-210.

SCI-210 is a unique formulation that combines cannabidiol (CBD) with CannAmide™, SciSparc's novel Palmitoylethanolamide formulation. This combination is intended to alleviate symptoms associated with ASD. The clinical trial is structured as a double-blind, randomized, and placebo-controlled study. The first five patients have already been enrolled and dosed, marking an important milestone in the trial's progress.

The trial plans to enroll a total of 60 children between the ages of five and 18, with each participant undergoing treatment for 20 weeks. The objective is to compare the effectiveness of SCI-210 therapy against standard CBD monotherapy in managing ASD symptoms. The trial incorporates three primary efficacy metrics: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician, and the determination of the effective therapeutic dose. The design of the trial was developed in consultation with the National Autism Research Center, a leading institution in autism research in Israel.

Oz Adler, Chief Executive Officer of SciSparc, expressed satisfaction with the pace of enrollment and emphasized the potential impact of the study. "People of all genders, ethnicities, and economic backgrounds can be diagnosed with ASD. Although ASD can be a lifelong disorder, treatments and services can improve a person’s symptoms and daily functioning. Consistent with our mission of improving people’s lives, we are happy with the ongoing pace of enrollment in the SCI-210 trial and expect that this study will generate new scientific data so that others may be better helped in the future," Adler stated.

ASD is a developmental condition affecting brain function, altering how individuals perceive and interact with others. This results in challenges in social interactions and communication. The term "spectrum" denotes the broad range of symptoms and severity levels associated with the disorder.

SciSparc Ltd. operates as a specialty clinical-stage pharmaceutical company, led by a seasoned team of executives and scientists. The company's primary mission is to develop and enhance a portfolio of technologies and assets centered around cannabinoid pharmaceuticals. SciSparc's current drug development initiatives include SCI-110, aimed at treating Tourette Syndrome and Alzheimer's disease-related agitation; SCI-160, focused on pain management; and SCI-210, targeting ASD and status epilepticus. Additionally, the company holds a controlling interest in a subsidiary that specializes in selling hemp seed oil-based products on Amazon Marketplace.

The company’s strategy is to initially commercialize SCI-210 in the Israeli market, with plans to expand globally following the necessary regulatory approvals. This trial represents a critical step in bringing a potentially transformative treatment to the market for those affected by ASD.

In conclusion, SciSparc Ltd.'s ongoing clinical trial for SCI-210 signifies a promising development in ASD treatment. With its innovative formulation and thorough clinical approach, the company aims to improve the quality of life for individuals with ASD and potentially broaden the scope of effective treatments available for this complex condition.