SciSparc Gets FDA Nod for Phase IIb Tourette Syndrome Trial

SciSparc Ltd., a clinical-stage pharmaceutical company based in Tel Aviv, Israel, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with Phase IIb clinical trials for its drug candidate SCI-110, aimed at treating Tourette Syndrome (TS). This approval comes just a month after SciSparc submitted its investigational new drug (IND) application to the FDA.

The clinical trial will take place at three prestigious medical centers: the Yale Child Study Center at the Yale School of Medicine in Connecticut, the Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. These sites have already received the necessary Institutional Review Board approvals and federal administration permissions.

Oz Adler, CEO of SciSparc, expressed excitement about this milestone, emphasizing that the swift approval by the FDA and promising results from previous Phase IIa trials bolster the company’s confidence in SCI-110. SciSparc aims to become a leading provider of safe and effective treatments for central nervous system disorders.

The Phase IIb clinical trial will focus on evaluating the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18 to 65 years. Participants will receive either SCI-110 or a placebo in a 1:1 randomization. The primary efficacy measure will be the Yale Global Tic Severity Scale, which will assess changes in tic severity at weeks 12 and 26 compared to baseline. The primary safety measure will involve assessing the frequency of serious adverse events across the participant pool and comparing those between the SCI-110 and placebo groups.

SciSparc Ltd. operates under the ticker symbol SPRC on Nasdaq. The company is led by a team of seasoned executives and scientists and specializes in developing therapies using cannabinoid pharmaceuticals. In addition to SCI-110 for TS and Alzheimer’s-related agitation, SciSparc is working on SCI-210 for autism spectrum disorder (ASD) and status epilepticus. The company also has a subsidiary that sells hemp seed oil-based products on Amazon Marketplace.