SciSparc announces initiation of Phase IIb trial of SCI-110 in TS

SciSparc announced the initiation of its Phase IIb clinical trial treating patients suffering from Tourette Syndrome with its SCI-110, proprietary drug candidate. The trial is being conducted under the regulation of the U.S. Food and Drug Administration, the Federal Institute for Drugs and Medical Devices in Germany and the Israeli Ministry of Health. SciSparc initiated the trial at the Tel Aviv Sourasky Medical Center in Israel 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. SCI-110 contains Dronabinol, with the endocannabinoid palmitoylethanolamide. 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 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. 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.