SciSparc Embarks on a Phase IIb Trial of THC-Based Treatment for Tourette Syndrome

Israeli-based clinical-stage pharmaceutical company SciSparc Ltd. SPRC is taking a significant step forward in the development of treatments for Tourette Syndrome (TS) by initiating a Phase IIb clinical trial for its drug candidate SCI-110. This proprietary medication is based on pharmaceutically graded Tetrahydrocannabinol (THC), and it seeks to provide a novel approach for managing the symptoms of TS—a condition characterized by involuntary motor and vocal tics often accompanied by numerous co-morbidities.

International Collaboration in Clinical Trials

SciSparc is collaborating with prestigious institutions across the globe to conduct this trial. Partnering with Yale University in the United States, Tel Aviv Sourasky Medical Center in Israel, and the Hannover Medical School in Germany, the company is set to explore the drug's efficacy, safety, and tolerability in patients. This international endeavor is regulated by corresponding authorities such as 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.

Unveiling SCI-110's Potential

SCI-110 is comprised of Dronabinol—an FDA-approved synthetic form of THC—and the endocannabinoid palmitoylethanolamide (PEA). It aims to stimulate cannabinoid receptors and inhibit the breakdown of endocannabinoids, enhancing THC uptake. This mechanism could lead to more effective oral administration, potentially reducing dosage requirements, side effects, and adverse events. The trial includes adult patients aged between 18 and 65, who will be randomized to receive either SCI-110 or a placebo, with the primary efficacy measure being the change in tic severity as assessed by the Yale Global Tic Severity Scale at weeks 12 and 26.

Encouraging Preliminary Results

Previous Phase IIA trials conducted at Yale University yielded promising results, with an average tic reduction of 21%—nearly 40% of participants saw a tic reduction of greater than 25%. The forthcoming trial aims to build on these findings to confirm SCI-110's potential benefits.

About SciSparc Ltd. SPRC

Headquartered in Tel Aviv, SciSparc is a specialty pharmaceutical company focused on developing cannabinoid-based pharmaceuticals. Its diverse drug development programs include SCI-110 for TS, Alzheimer's disease, and agitation; SCI-160 for pain; and SCI-210 for ASD and status epilepticus. They also hold a controlling interest in a subsidiary selling hemp seed oil-based products on Amazon.com.

Investment Implications and Forward-Looking Statements

The initiation of Phase IIb clinical trials by SciSparc signifies a potential advancement in TS treatment options. Investors are advised to watch for updates on the trial’s progress and consider the inherent risks and uncertainties. Historical outcomes do not guarantee future results, and SciSparc's statements are predictive in nature, reflecting current expectations rather than guaranteed performance.

SciSparc, ClinicalTrial, TS