Tuesday, March 07, 2023
SciSparc Ltd., a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that it has successfully manufactured clinical batches of its top-tier drug candidate SCI-110 to be used in its upcoming multinational, multicenter, Phase IIb trial for Tourette Syndrome ("TS").
SCI-110 batches were manufactured by Procaps Group S.A. (“Procaps”), a global leader in contract development and manufacturing services and in soft-gel advanced technologies for the global pharmaceutical industry, and under Good Manufacturing Process conditions to comply with the U.S. Food and Drug Administration (the “FDA”), 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 (“Yale’s IRB”).
TS is a movement and neurobehavioral disorder characterized by chronic motor and vocal tics. With the onset before age 18, about half to two-thirds of TS cases improve during adolescence, while adults are generally more severe patients. Tics may be associated with a premonitory sensation to perform a specific action, which may lead to “relief” once performed.
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 (between 18 and 65 years of age) 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.
“Today’s announcement is the culmination of a long period of efforts by the Procaps team focused on the development of a reliable manufacturing process to enable production of SCI-110 in an innovative unigel platform” said Oz Adler, Chief Executive Officer of SciSparc. “With the successful manufacturing of the clinical batches, we are one step closer to initiate this important clinical trial.”