SciSparc Announces Ethics Committee Approval to Conduct a Phase IIb Trial in Tourette Syndrome
SciSparc Ltd. (NASDAQ: SPRC) has received Ethics Committee approvals for its Phase IIb clinical trial of SCI-110 targeting Tourette Syndrome (TS) at Hannover Medical School and Tel Aviv Sourasky Medical Center. This phase aims to assess the efficacy, safety, and tolerability of SCI-110 in adults aged 18-65, using the Yale Global Tic Severity Scale for measuring tic severity over 12 and 26 weeks. While the trial awaits health ministry approvals, the company continues to identify additional clinical sites to expedite patient enrollment. Positive results from earlier studies at Yale University encourage further development.
- Ethics Committee approval received for Phase IIb trial, signaling regulatory progress.
- Previous Phase IIa study showed significant symptom reduction in Tourette Syndrome patients.
- Company plans to expedite patient enrollment by exploring additional clinical sites.
- The trial launch is pending approvals from health ministries, delaying progress.
Ethics Committee approval received from the two sites that will conduct the SCI-110 trial in Germany and Israel
TEL AVIV, Israel, May 26, 2022 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced it received Ethics Committee approvals from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel, to conduct the Company’s Phase IIb clinical study for SCI-110 in patients suffering from Tourette Syndrome ("TS"). The Company is evaluating additional clinical sites to join the Phase 2b trial to expedite patient enrollment in a timely manner.
“We are delighted and honored to receive Ethics Committee approval, an important step toward initiation of our Phase IIb trial in TS,” commented Oz Adler, SciSparc's Chief Executive Officer. "We are encouraged by the Phase IIa study conducted at Yale University, which demonstrated that SCI-110 was able to significantly decrease symptoms over time in adult subjects with TS, and we are excited about achieving another significant milestone to further the Company's clinical program. TS is one of our leading indications and we believe that we could make a real change in patients' lives and their quality of life while reducing side effects, thanks to our unique technology."
TS is a movement and neurobehavioral disorder characterized by chronic motor and vocal tics. With onset before age 18, about half to two-thirds of TS cases improve during adolescence, while adults are generally more severe patients. Tics may be associated with a premonitory sensation to perform a specific action, which may lead to “relief” once performed.
The objective of this Phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over study 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). The patients will be randomized in a 1:1 ratio to receive either SCI-110 or SCI-110 matched placebo. The primary efficacy objective of the study will be to assess tic severity change using Yale Global Tic Severity Scale (YGTSS-R-TTS), the most commonly used measure in clinical trials, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the study will be to assess absolute and relative frequencies of serious adverse events for the entire population and separately for the SCI-110 and placebo groups.
The launch of the trial is pending approvals by the Ministry of Health in both countries.
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 cannabidiol (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 autism spectrum disorder and status epilepticus.
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 is using forward-looking statements when it discusses the potential benefits of SCI-110 treatment and its plans for the Phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over study, and SciSparc’s plans to explore additional clinical sites to join the clinical trial. Historic 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 April 28, 2022, 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.
Investor Contact:
IR@scisparc.com
Tel: +972-3-6167055
FAQ
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