SciSparc Submits IND Application to US FDA For Phase Iib Trial for Tourette Syndrome

SciSparc Submits IND Application to US FDA For Phase Iib Trial for Tourette Syndrome

By, Admin 23 September 2024

Overview

SciSparc Ltd., a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, has taken a major step forward with its proprietary SCI-110 for the treatment of Tourette syndrome (TS), with its submission of an Investigational New Drug application to the US Food and Drug Administration for its phase IIb clinical trial, as previously announced on August 23, 2024.

Phase IIb Clinical Trial

  • 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 (“Sourasky”). 
  • The Company has already secured the Institutional Review Board approvals from all three clinical sites, the Israeli Ministry of Health's approval for the clinical trial at Sourasky, and approval from the Federal Institute for Drugs and Medical Devices in Germany for conducting the trial at the Hannover Medical School.

Objective of the Trial

  • 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 the Company: SciSparc Ltd.

  • 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.

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