Pharma Focus Europe

SciSparc Receives Approval to conduct its Phase IIb Clinical Trial for SCI-110 to treat Tourette Syndrome

Friday, March 10, 2023

SciSparc Ltd., a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced the approval of the Israeli Ministry of Health to conduct its clinical trial titled “A randomized, double-blind, placebo controlled, cross-over study to evaluate the efficacy, safety and tolerability of daily oral SCI-110 in treating adults with Tourette Syndrome”.

The first clinical site to receive approval to conduct the trial is Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, under the leadership of Prof. Tanya Gurevich, Head of Movement Disorders Unit, Department of Neurology. The Company also intends to conduct the clinical trial in various sites including Yale Child Study Center, Yale School of Medicine, Connecticut, USA, under the leadership of Dr. Michael H. Bloch and Hannover Medical School, Hannover, Germany, under the leadership of Prof. Muller-Vahl, Department of Psychiatry.  The launch of the clinical trial at Yale University is subject to approvals by the United States Food and Drug Administration and Yale University’s institutional review board and the launch of the clinical trial at Hannover Medical School is subject to approvals by the German Federal Institute for Drugs and Medical Devices.

“We are excited to be granted approval to conduct our Tourette Syndrome (“TS”) clinical trial in Israel. This is another step for the Company's progress in the developments of much needed treatment for TS. We are proud to be able to collaborate with centers of excellence around the world such as Yale University, Hannover Medical School and the Tel Aviv Sourasky Medical Center,” said Oz Adler, Chief Executive Officer of SciSparc.

"TS is estimated to affect 0.5-1% of the world's population, however the very few available treatments have limited efficacy and questionable safety. Based on previous results from our phase IIa trial conducted at the same site at Yale University, we believe our proprietary SCI-110 treatment has the potential to help TS patients around the world," Adler added.  

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 18 and 65 years of age) using daily oral treatment. The patients will be randomized in a 1:1 ratio to receive either SCI-110 or a SCI-110 matched placebo. The primary efficacy objective of the study will be to assess tic severity change using the Yale Global Tic Severity Scale, 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 study 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.

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