SciSparc completes production of SCI-110 for upcoming trial in Tourette Syndrome

SciSparc has manufactured clinical batches of its drug candidate SCI-110 to be used in its upcoming multinational, multicenter, Phase IIb trial for Tourette Syndrome. SCI-110 batches were manufactured by Procaps Group and under Good Manufacturing Process conditions to comply with the U.S. Food and Drug Administration, the European Medicines Agency and Israeli Ministry of Health rigorous requirements. The Company has already received ethics committee approvals from the Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel. The Company is currently preparing to submit a request for approval to the Institutional Review Board of Yale University, Connecticut, USA. The objective of this Phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over study is to evaluate the efficacy, safety and tolerability of SciSparc’s proprietary drug candidate SCI-110 in adult patients using oral treatment daily. 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. The launch of the trial is subject to approvals by FDA, the German Federal Institute for Drugs and Medical Devices , the Israeli Ministry of Health and Yale’s IRB.