SciSparc to conduct trial at Yale University in the USA, Tel Aviv Sourasky Medical Center in Israel and the Hannover Medical School in Germany
TEL AVIV, Israel, Nov. 10, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced the initiation of its Phase IIb clinical trial treating patients suffering from Tourette Syndrome (TS) with its SCI-110, proprietary drug candidate.
The trial is being conducted under the regulation of the U.S. Food and Drug Administration (FDA), the Federal Institute for Drugs and Medical Devices in Germany (BfArM) and the Israeli Ministry of Health. SciSparc initiated the trial at the Tel Aviv Sourasky Medical Center in Israel (Sourasky) and is expected to proceed with its U.S. and Germany-based medical sites. The Company has already secured institutional review board approval from all three clinical sites, approval from the Israeli Ministry of Health for the clinical trial at Sourasky, and approval from BfArM for conducting the trial at the Hannover Medical School.
TS is a movement and neurobehavioral disorder characterized by motor and vocal tics and is highly linked with co-morbidities. As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, there is a clear unmet medical need for the management of TS.
SCI-110 contains Dronabinol (FDA approved synthetic form of THC), with the endocannabinoid palmitoylethanolamide (PEA). Designed to stimulate cannabinoid receptors across the central nervous system and inhibit the metabolic degradation of endocannabinoids in order to improve uptake of THC, the expected benefits of SCI-110 are more efficient through oral administration, and in turn a decrease in dosage requirements, side effects and adverse events.
The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between 18 and 65 years of age) using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the trial is to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups.
Results from the Company's Phase IIA clinical trial conducted at Yale University demonstrated an average tic reduction of 21% across the entire sample with almost 40% of the patients experiencing greater than 25% in tic reduction as defined by YGTSS-TTS (a clinician-rated instrument considered as the gold standard for assessing tics in patients with TS). In addition, the medication was generally well-tolerated by subjects and 12 out of the 16 subjects elected to continue into a 24-week extension phase of the trial.
About SciSparc Ltd. (Nasdaq: SPRC):
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 CBD: SCI-110 for the treatment of Tourette Syndrome, for the treatment of 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 controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on the Amazon.com Marketplace.
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 is using forward-looking statements when it discusses: the trial’s objective to evaluate efficacy, safety and tolerability of SCI-110; and the trial is expected to proceed with its U.S. and Germany-based medical sites. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements 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 May 1, 2023, and in subsequent filings with the U.S. 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 were made, whether as a result of new information, future events or circumstances or otherwise.