SciSparc Secures FDA Green Light to US Launch of its Pivotal Phase IIb Clinical Trial for Breakthrough Tourette Syndrome Treatment

Rhea-AI Summary

SciSparc (Nasdaq: SPRC) has received FDA approval to proceed with its Phase IIb clinical trials in the U.S. for SCI-110, a potential breakthrough treatment for Tourette Syndrome (TS) in adults. This approval comes just one month after the application submission, marking a significant milestone for the company. The trial will be conducted at three leading centers: Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center.

The study aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65 years. The primary efficacy objective is to assess tic severity change using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. SciSparc's CEO, Oz Adler, emphasized the unmet medical need for TS management and highlighted the promising results from their Phase IIa trial, which showed an average tic reduction of 21% across the entire sample.

Positive

• FDA approval to proceed with Phase IIb clinical trials for SCI-110 in the U.S.
• Rapid FDA response, approving the study only one month after application submission
• Phase IIa trial results showed an average tic reduction of 21%, with 40% of patients experiencing over 25% tic reduction
• Trial to be conducted at three globally recognized medical centers
• Institutional Review Board approvals secured from all three clinical sites

Negative

• None.

FDA confirms that SciSparc’s study may proceed only a month after application submission

TEL AVIV, Israel, Sept. 30, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced that the U.S. Food and Drug Administration (“FDA”) has confirmed that its investigational new drug (“IND”) application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome (“TS”). This previously announced FDA approval is one of the most important milestones of SciSparc to date.

Oz Adler, Chief Executive Officer of SciSparc, commented “As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, we believe there is a clear unmet medical need for the management of TS. The desired therapy for TS should allow for a notable effectiveness, addressing as many symptoms as possible. The therapy of choice should also have a favorable safety profile, allowing for a high patient’s drug compliance. In light of the results from our Phase IIa clinical trial conducted at Yale University that showed an average tic reduction of 21% across the entire sample with almost 40% of the patients experiencing greater than 25% in tic reduction, we believe that our innovative drug candidate SCI-110 has the potential to be this desired therapy”

The phase IIb clinical trial will be conducted at three global leading centers of excellence: the Yale Child Study Center at the Yale School of Medicine in Connecticut, United States, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center in Israel. The Company has already secured the Institutional Review Board approvals from all three clinical sites, as well as approval from all related federal administrations.

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 the ages of 18 and 65 years) 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 weeks 12 and 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.

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 TS, for the treatment of Alzheimer's disease and agitation; 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 Amazon 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 belief regarding an unmet medical need for the management of TS; the parameters for the desired therapy for TS; its belief that its innovative drug candidate SCI-110 has the potential to become the desired therapy for TS; and the format, structure and objective of the clinical trials for the phase IIb clinical trial. 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 April 1, 2024, 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 3-761-7108

FAQ

What is the purpose of SciSparc's Phase IIb clinical trial for SCI-110 (SPRC)?

The Phase IIb clinical trial aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients (18-65 years) with Tourette Syndrome, using a daily oral treatment.

Where will SciSparc (SPRC) conduct its Phase IIb clinical trial for SCI-110?

The trial will be conducted at three centers: Yale Child Study Center in Connecticut, USA; Hannover Medical School in Germany; and Tel Aviv Sourasky Medical Center in Israel.

What were the results of SciSparc's (SPRC) Phase IIa clinical trial for SCI-110?

The Phase IIa trial, conducted at Yale University, showed an average tic reduction of 21% across the entire sample, with nearly 40% of patients experiencing greater than 25% tic reduction.

How will the efficacy of SCI-110 be measured in SciSparc's (SPRC) Phase IIb trial?

The primary efficacy objective is to assess tic severity change using the Yale Global Tic Severity Scale at weeks 12 and 26 of the double-blind phase compared to baseline.