SciSparc Successfully Completed Production of its Proprietary Drug Candidate for its Upcoming Clinical Trial on Tourette Syndrome

SciSparc Ltd. recently announced it has successfully manufactured clinical batches of its top-tier drug candidate SCI-110 to be used in its upcoming multinational, multicenter, Phase 2b 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 US 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 2b 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.”

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 cannabidiol (CBD): SCI-110 for the treatment of Tourette syndrome, for the treatment of Alzheimer’s disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus.