SciSparc Awaiting Approval For Phase IIb Study Of Its Dronabinol Based Drug For Treatment Of Tourette Syndrome

SciSparc Ltd. SPRC, a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, has successfully completed the development of its top-tier drug candidate SCI-110 to be used in its upcoming multinational, multi-center, Phase IIb study for Tourette syndrome ("TS").

The company received ethics committee approvals from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel. SCI-110 is developed and manufactured by Procaps Group S.A., a leader in contract development and manufacturing services in soft-gel advanced technologies for the global pharmaceutical industry.

"Completing the development of our unique drug candidate SCI-110 for the upcoming Phase IIb trial is another significant milestone for the company, making SciSparc well positioned to introduce an impactful treatment for TS patients that have very limited treatment options today," stated Oz Adler, SciSparc's CEO. "Our singular objective in developing SCI-110 is to develop a safe and effective treatment for this devastating, unmet medical need as soon as possible; and this milestone brings us one step closer.”

TS is a movement and neurobehavioral disorder characterized by chronic motor and vocal tics. With 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 Yale global tic severity scale (YGTSS-R-TTS), 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 pending approvals by the Ministry of Health in both Germany and Israel.