SciSparc Announces Expanding its Clinical Operations to Include a U.S. Site Towards its Phase IIb Trial with its Proprietary SCI-110 for the Treatment of Tourette Syndrome

Rhea-AI Summary

SciSparc Ltd. (Nasdaq: SPRC) has initiated preparations for an Investigational New Drug Application (IND) with the FDA for a Phase IIb clinical trial of its drug, SCI-110, targeting Tourette Syndrome (TS). Following promising Phase IIa trial results showing a 21% reduction in tic symptoms among treatment-resistant patients, the company aims to expand clinical sites to the U.S. Approval has been granted by two medical centers in Germany and Israel to participate in the upcoming trial, which will evaluate treatment efficacy and safety.

Positive

• Initiation of IND preparation for SCI-110 could accelerate drug development.
• Positive Phase IIa trial results with a 21% reduction in tic symptoms.
• Clinical sites in the U.S. will enhance trial reach and patient recruitment.
• Ethics Committee approval from Hannover Medical School and Tel Aviv Sourasky Medical Center for Phase IIb trial involvement.

Negative

• None.

TEL AVIV, Israel, July 08, 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 has started the process of preparing for an Investigational New Drug Application (“IND”) with the U.S. Food and Drug Administration (“FDA”) for its Phase IIb clinical trial for SCI-110 in patients suffering from Tourette Syndrome ("TS").

The work towards an IND submission is intended to open a U.S. clinical site that will take part in the phase IIb trial.

“We are very excited about expanding our clinical sites to the U.S., especially after positive results obtained in a clinical trial led by Prof. Bloch M.D., M.S., an associate Professor in the Child Trial Center at Yale University, using our proprietary drug candidate," commented Dr. Adi Zuloff-Shani, SciSparc’ s Chief Technologies Officer. "Expanding this trial, is part of our overall efforts to expedite the development of SCI-110 for TS, which is a greatly underserved therapeutic area. We believe our approach has significant advantages over available treatments and it is our intention to do everything in our ability to accelerate our trial in order to reach patients who are in need for effective treatment".

Previously, a Phase IIa trial conducted at the same site at Yale University showed that trial patients, which were TS medication-refractory, had a reduction of tic symptoms of 21% across the entire sample. Improvement over time with treatment was also observed when generalized linear models were used to analyze repeated measures data on the Yale Global Tic Severity Scale (“YGTSS-TTS”). In addition, no evidence of adverse events of clinical concern were observed. Based on these positive results, the Company is currently advancing into a phase IIb trial. The objective of this phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over 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). 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 trial will be to assess tic severity change using 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 trial 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 Company recently announced it has received the Ethics Committee approval from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel, which will be the two first sites of the phase IIb trial.

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.

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 trial, 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

What is the purpose of the IND for SciSparc's SCI-110?

The IND is necessary for initiating the Phase IIb clinical trial of SCI-110 for Tourette Syndrome.

What were the results of the Phase IIa trial for SCI-110?

The Phase IIa trial showed a 21% reduction in tic symptoms among med-resistant Tourette Syndrome patients.

Which institutions are involved in the upcoming Phase IIb trial for SPRC?

The Tel Aviv Sourasky Medical Center and Hannover Medical School are the first sites for the Phase IIb trial.

What is the target condition for SCI-110?

SCI-110 is being developed for the treatment of Tourette Syndrome.

What is SciSparc's stock symbol?

SciSparc's stock symbol is SPRC.