SciSparc Submits IND to FDA for Phase IIb Tourette Syndrome Trial

TEL AVIV, Israel, Sept. 18, 2024 - SciSparc Ltd. (Nasdaq: SPRC), a clinical-stage pharmaceutical company specializing in therapies for central nervous system disorders and rare diseases, has announced a significant advancement in its SCI-110 program for treating Tourette Syndrome (TS). The company has recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a phase IIb clinical trial of SCI-110, following an announcement on August 23, 2024.

The phase IIb clinical trial will take place at three renowned medical institutions: the Yale Child Study Center at Yale School of Medicine in Connecticut, USA, the Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. SciSparc has already obtained the necessary Institutional Review Board approvals from all three sites. Additionally, it has secured approval from the Israeli Ministry of Health for Sourasky and from Germany's Federal Institute for Drugs and Medical Devices for Hannover Medical School.

The primary aim of this clinical trial is to assess the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18 to 65 through daily oral treatment. Participants will be randomly assigned in a 1:1 ratio to receive either SCI-110 or a placebo that matches SCI-110. The main efficacy goal is to evaluate changes in tic severity using the Yale Global Tic Severity Scale, a widely recognized measure in such studies, at weeks 12 and 26 during the double-blind phase compared to baseline. The primary safety objective is to determine the absolute and relative frequencies of serious adverse events for both the overall population and the individual SCI-110 and placebo groups.

About SciSparc Ltd. (Nasdaq: SPRC):

SciSparc Ltd. is a clinical-stage pharmaceutical company directed by an experienced team of executives and scientists. The company focuses on developing and enhancing a range of technologies and assets based on cannabinoid pharmaceuticals. Its current drug development programs include SCI-110 for treating Tourette Syndrome and Alzheimer's disease with agitation, and SCI-210 for addressing Autism Spectrum Disorder (ASD) and status epilepticus. Additionally, SciSparc holds a controlling interest in a subsidiary that markets hemp seed oil-based products on Amazon Marketplace.