SciSparc Gets Ethics Committee Approval In Germany And Israel Sites To Conduct A Phase IIb Trial In Tourette Syndrome

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SciSparc Ltd. SPRC announced that it received Ethics Committee approvals from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel, to conduct the company’s Phase IIb clinical study for SCI-110 in patients suffering from Tourette Syndrome ("TS"). The company is evaluating additional clinical sites to join the Phase 2b trial to expedite patient enrollment in a timely manner.

“We are delighted and honored to receive Ethics Committee approval, an important step toward initiation the of our Phase IIb trial in TS,” commented Oz Adler, SciSparc's Chief Executive Officer. "We are encouraged by the Phase IIa study conducted at Yale University, which demonstrated that SCI-110 was able to significantly decrease symptoms over time in adult subjects with TS, and we are excited about achieving another significant milestone to further the company's clinical program. TS is one of our leading indications and we believe that we could make a real change in patients' lives and their quality of life while reducing side effects, thanks to our unique technology."

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). The patients will be randomized in a 1:1 ratio to receive either SCI-110 or 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 countries.

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