SciSparc Receives Final Approval to Commence its Phase IIb Clinical Trial for SCI-110 to treat Tourette Syndrome

Rhea-AI Summary

SciSparc Ltd. (NASDAQ: SPRC) has received final approval from the Tel Aviv Sourasky Medical Center for its Phase IIb Clinical Trial of SCI-110, aimed at treating Tourette Syndrome (TS). The trial will assess the drug's efficacy, safety, and tolerability in adults aged 18-65, using a randomized, double-blind, placebo-controlled method. The primary outcomes will be measured using the Yale Global Tic Severity Scale over 12 and 26 weeks. Prof. Tanya Gurevich will lead the trial at the Tel Aviv site, with additional trials planned at Yale University and Hannover Medical School, pending regulatory approvals.

Positive

• Final approval received for Phase IIb clinical trial of SCI-110 targeting Tourette Syndrome.
• Study designed to evaluate drug's efficacy and safety, based on promising Phase IIa results.

Negative

• Regulatory approvals pending for trials at Yale University and Hannover Medical School.
• Current limited treatment options for Tourette Syndrome present high expectations for SCI-110.

The Tel Aviv Sourasky Medical Center granted its final approval to use SCI-110 in a clinical trial

TEL AVIV, Israel, April 04, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (the "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 has been granted final approval from the Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, required to commence the Company’s Phase IIb Clinical Trial for SCI-110 to treat Tourette Syndrome (“TS”).

The Trial is titled “A randomized, double-blind, placebo controlled, cross-over study to evaluate the efficacy, safety and tolerability of daily oral SCI-110 in treating adults with Tourette Syndrome”.

The first clinical site to receive approval to initiate the trial is the Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, under the leadership of Prof. Tanya Gurevich, Head of Movement Disorders Unit, Department of Neurology.

The Company also intends to conduct the clinical trial in various sites including Yale Child Study Center, Yale School of Medicine, Connecticut, USA, under the leadership of Dr. Michael H. Bloch and Hannover Medical School, Hannover, Germany, under the leadership of Prof. Muller-Vahl, Department of Psychiatry. The launch of the clinical trial at Yale University is subject to approvals by the United States Food and Drug Administration and Yale University’s institutional review board and the launch of the clinical trial at Hannover Medical School is subject to approvals by the German Federal Institute for Drugs and Medical Devices.

“We are thrilled to launch our Phase IIb Clinical Trial in Israel and start enrollment of patients suffering from Tourette Syndrome. This trial is a key milestone in SciSparc's pursuit of lower-dose, THC-based treatment that is potentially safer and more effective for patients than all the current available treatments," said Oz Adler, Chief Executive Officer of SciSparc.

"TS is estimated to affect 0.5-1% of the world's population, however the very few available treatments have limited efficacy and questionable safety. Based on previous results from our phase IIa trial conducted at Yale University, we believe our proprietary SCI-110 treatment has the potential to help TS patients around the world," Adler added.

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 daily oral treatment. The patients will be randomized in a 1:1 ratio to receive either SCI-110 or a SCI-110 matched placebo. The primary efficacy objective of the study will be to assess tic severity change using the Yale Global Tic Severity Scale, 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.

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. The Company also has a majority-owned subsidiary whose business focusses on the sale of hemp-based products on the Amazon.com marketplace.

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 its intention to conduct the SCI-110 clinical trial at Yale University and Hannover Medical School, the design and objective of Phase IIb clinical trial for treatment of TS, the pending further regulatory approvals in the United States and Germany and the Company’s pursuit of lower-dose THC-based treatment that is potentially safer and more effective for patients than all currently available treatments. 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 U.S. Securities and Exchange Commission (the “SEC”) on April 28, 2022, and in subsequent filings with the SEC. 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

What is the purpose of the Phase IIb clinical trial for SCI-110 by SciSparc?

The trial aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adults with Tourette Syndrome.

When did SciSparc receive approval to start the clinical trial for SCI-110?

SciSparc received final approval on April 4, 2023.

Where will the clinical trial for SCI-110 be conducted?

The trial will be conducted at the Tel Aviv Sourasky Medical Center and planned sites at Yale University and Hannover Medical School.

What are the primary endpoints of the SCI-110 clinical trial?

The primary endpoints include assessing changes in tic severity using the Yale Global Tic Severity Scale at 12 and 26 weeks.

What is the significance of SCI-110 for Tourette Syndrome patients?

SCI-110 aims to provide a potentially safer and more effective treatment option compared to current available therapies.