SciSparc Gets FDA Approval for Phase IIb Trial of Tourette Syndrome Treatment

SciSparc Ltd., a clinical-stage pharmaceutical company listed on Nasdaq as SPRC, has announced a significant milestone in the development of its treatment for Tourette Syndrome (TS). The U.S. Food and Drug Administration (FDA) has confirmed that SciSparc's investigational new drug (IND) application for its pioneering drug candidate, SCI-110, can proceed to Phase IIb clinical trials. This approval, granted only a month after the application was submitted, marks a crucial step forward for the company.

SciSparc specializes in developing therapies for central nervous system disorders and rare diseases. The company’s CEO, Oz Adler, highlighted the pressing need for more effective and safer treatments for TS, pointing out that current medications offer limited symptom management and pose safety concerns. He emphasized that SCI-110 aims to meet these unmet medical needs, citing results from a Phase IIa clinical trial at Yale University which showed promising outcomes. The trial demonstrated an average tic reduction of 21% across participants, with almost 40% of patients experiencing more than a 25% reduction in tics.

The upcoming Phase IIb clinical trial will take place at three leading medical centers: the Yale Child Study Center at Yale School of Medicine in the United States, Hannover Medical School in Germany, and Tel Aviv Sourasky Medical Center in Israel. All three sites have secured the necessary Institutional Review Board approvals and federal permissions.

This trial aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adults aged 18 to 65 years, who will receive daily oral treatments. Participants will be randomized in a 1:1 ratio to receive either SCI-110 or a placebo that matches SCI-110. The primary efficacy measure will be the change in tic severity, assessed using the Yale Global Tic Severity Scale. This scale is the most widely utilized measure in clinical trials for TS and will be evaluated continuously at 12 and 26 weeks of the double-blind phase compared to baseline. Safety assessments will focus on the absolute and relative frequencies of serious adverse events across the entire study population and within the separate SCI-110 and placebo groups.

SciSparc Ltd. is led by a team of experienced executives and scientists dedicated to advancing cannabinoid-based pharmaceuticals. The company's primary focus is on creating a diverse portfolio of technologies and assets that leverage THC and non-psychoactive CBD. Currently, SciSparc’s drug development programs include SCI-110 for both TS and Alzheimer's disease-related agitation, and SCI-210 for conditions such as autism spectrum disorder (ASD) and status epilepticus. In addition to its pharmaceutical endeavors, SciSparc holds a controlling interest in a subsidiary that sells hemp seed oil-based products on Amazon Marketplace.

The company's efforts are directed at bringing innovative therapies to market, particularly for conditions where existing treatments fall short. With the FDA’s recent approval for the Phase IIb clinical trial of SCI-110, SciSparc is poised to make significant strides in the treatment of Tourette Syndrome.