SciSparc Ltd. announced the initiation of its Phase IIb clinical trial treating patients suffering from Tourette Syndrome (TS) with its SCI-110, proprietary drug candidate. The trial is being conducted under the regulation of the U.S. Food and Drug Administration (FDA), the Federal Institute for Drugs and Medical Devices in Germany (BfArM) and the Israeli Ministry of Health. SciSparc initiated the trial at the Tel Aviv Sourasky Medical Center in Israel (Sourasky) and is expected to proceed with its U.S. and Germany-based medical sites.

The Company has already secured institutional review board approval from all three clinical sites, approval from the Israeli Ministry of Health for the clinical trial at Sourasky, and approval from BfArM for conducting the trial at the Hannover Medical School. TS is a movement and neurobehavioral disorder characterized by motor and vocal tics and is highly linked with co-morbidities. As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, there is a clear unmet medical need for the management of TS.

TS contains Dronabinol (FDA approved synthetic form of THC), with the endocannabinoid palmitoylethanolamide (PEA). Designed to stimulate cannabinoid receptors across the central nervous system and inhibit the metabolic degradation of endocannabinoids in order to improve uptake of THC, the expected benefits of SCI-110 are more efficient through oral administration, and in turn a decrease in dosage requirements, side effects and adverse events. 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 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 week 12 and week 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.

Results from the Company's Phase IIA clinical trial conducted at Yale University demonstrated an average tic reduction of 21% across the entire sample with almost 40% of the patients experiencing greater than 25% in tic reduction as defined by YGTSS-TTS (a clinician-rated instrument considered as the gold standard for assessing tics in patients with TS). In addition, the medication was generally well-tolerated by subjects and 12 out of the 16 subjects elected to continue into a 24-week extension phase of the trial.