SciSparc announces enrollment of first five patients in clinical trial of its innovative SCI-210 treatment

The clinical study for SCI-210 Is in Israel. The company then aims to commercialize SCI-210, initially on the Israeli market.

TEL AVIV, Israel, Aug. 19, 2024 (GLOBE NEWSWIRE) — SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a clinical-stage specialty pharmaceutical company focused on developing therapies to treat central nervous system disorders, today announced that the first five patients have been enrolled and dosed in the ongoing clinical trial in children with Autism Spectrum Disorders (“ASD”) at Soroka Medical Center in Israel.

The double-blind, randomized, placebo-controlled study will utilize SciSparc's proprietary SCI-210, an innovative combination of cannabidiol (“CBD”) and CannAmide™ (SciSparc's novel palmitoylethanolamide formulation) designed to alleviate ASD symptoms. SciSparc will enroll 60 subjects between the ages of five and 18 for 20 weeks to assess how SCI-210 therapy compares to standard CBD monotherapy in treating ASD symptoms.

The Company's goal is to sell SCI-210 initially in Israel and then, subject to obtaining the necessary regulatory approvals, in other countries.

The study has three primary efficacy measures: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the clinician-administered Clinical Global Impressions-Improvement (CGI-I), and the effective therapeutic dose. The study was designed in consultation with the National Autism Research Center, the leading autism research center in Israel.

“People of any gender, ethnicity, and economic background can be diagnosed with ASD. Although ASD can be a lifelong disorder, treatments and services can improve a person's symptoms and everyday functioning. In keeping with our mission to improve people's lives, we are pleased with the continued pace of enrollment in the SCI-210 study and expect this study to provide new scientific data so that others can be better served in the future,” said Oz Adler, Chief Executive Officer of SciSparc.

ASD is a disorder related to brain development that affects how a person perceives and interacts with others, leading to problems with social interaction and communication. The term “spectrum” in ASD refers to the wide range of symptoms and levels of severity.

About SciSparc Ltd. (Nasdaq: SPRC):

SciSparc Ltd. is a clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc is focused on developing and expanding a portfolio of cannabinoid pharmaceutical-based technologies and assets. With this focus, the Company is currently involved in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette syndrome, Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of ASD and status epilepticus. The Company also owns a majority interest in a subsidiary whose business is focused on selling hemp seed oil-based products on Amazon Marketplace.

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Forward-looking statements:

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. For example, SciSparc uses forward-looking statements when discussing the expected course and design of the clinical trial, its expected commercialization strategy and its view on the course and effect of the clinical trial. Historical results of scientific research and clinical and preclinical studies do not guarantee that the conclusions of future research or studies will lead to identical or even similar conclusions. Because such statements relate to future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and SciSparc's actual results, performance or achievements may differ materially from those described or implied in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in SciSparc's Annual Report on Form 20-F filed with the SEC on April 1, 2024, and in subsequent filings with the Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they are made, whether as a result of new information, future events or circumstances or otherwise.

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