SciSparc Submitted IND Application to the FDA for SCI-110 Phase 2b Clinical Trial for Patients With Tourette Syndrome
SciSparc Ltd. recently announced the submission of an Investigational New Drug (IND) application with the US FDA for its Phase 2b clinical trial for its proprietary SCI-110 for the treatment of Tourette Syndrome (TS).
“SciSparc is in a unique position to address the challenges associated with current TS treatments,” said SciSparc’s Chief Executive Officer, Oz Adler. “We believe that our proprietary SCI-110, comprised of dronabinol and palmitoylethanolamide, has the potential to revolutionize the way TS is treated. Commencing the clinical trial is the culmination of diligent work by the SciSparc team, together with leading researchers in the field.”
The Phase 2b 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.
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.
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. With this focus, the company is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of TS, for the treatment of Alzheimer’s disease and agitation; and SCI-210 for the treatment of ASD and status epilepticus. The company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on the Amazon.com Marketplace.
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