SciSparc Ltd. Embarks on Transformative Phase IIb Trial for Tourette Syndrome Using THC-Based Medication

SciSparc Ltd. SPRC, a Tel Aviv-based clinical-stage pharmaceutical company specializing in cannabinoid-based drug development, has made a groundbreaking announcement regarding the advancement of its treatments for central nervous system disorders. The company has initiated a Phase IIb clinical trial to evaluate the efficacy of its proprietary drug candidate SCI-110 in patients with Tourette Syndrome (TS), a condition characterized by motor and vocal tics, often associated with other comorbidities.

International Collaboration for Groundbreaking Research

In an effort to revolutionize TS treatments, SciSparc is collaborating with prestigious institutions around the globe. This includes Yale University in the USA, Tel Aviv Sourasky Medical Center in Israel, and the Hannover Medical School in Germany. The trial is regulated by health authorities across these regions, namely the U.S. Food and Drug Administration (FDA), the Federal Institute for Drugs and Medical Devices in Germany (BfArM), and the Israeli Ministry of Health.

Innovative Medication’s Potential Impact

SCI-110 contains Dronabinol, an FDA-approved synthetic form of THC, combined with the endocannabinoid palmitoylethanolamide (PEA). This blend is designed to interact with cannabinoid receptors in the central nervous system and enhance THC's uptake, potentially reducing the required dosage and minimizing side effects. The trial aims to establish the safety, tolerability, and effectiveness of SCI-110, with the hope of addressing the unmet medical needs in TS management.

Assessing Effectiveness and Safety

The comprehensive trial will involve adult patients and will utilize the Yale Global Tic Severity Scale to assess the primary efficacy objective: a change in tic severity at the 12th and 26th week compared to the baseline. Additionally, the safety of SCI-110 will be rigorously evaluated through the monitoring of serious adverse events in comparison to a placebo group.

Hopeful Outcomes

Previous Phase IIA clinical trial results at Yale University have been promising, with subjects showing an average tic reduction of 21% and a significant portion experiencing over 25% reduction. Moreover, the medication was generally well-tolerated, leading to extended participation in the trial. These positive outcomes lead to optimistic expectations for the upcoming Phase IIb study.

About SciSparc Ltd. SPRC

SPRC's mission is to pioneer a portfolio of cannabinoid pharmaceuticals. Its range of drug development programs targets various conditions such as Alzheimer's disease, pain, ASD, status epilepticus, and of course, Tourette Syndrome. Included in SciSparc's endeavors is a subsidiary dedicated to the distribution of hemp seeds oil-based products.

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