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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.