SciSparc Submitted IND Application to FDA for SCI-110 Phase IIb Tourette Syndrome Trial

SciSparc Ltd. (Nasdaq: SPRC), a clinical-stage pharmaceutical company specializing in therapies for central nervous system disorders and rare diseases, has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The application is for a phase IIb clinical trial of SciSparc's proprietary drug, SCI-110, aimed at treating Tourette Syndrome (TS).

SciSparc’s CEO, Oz Adler, highlighted the unique position of the company in addressing the challenges faced by existing TS treatments. Adler expressed confidence in SCI-110, which combines dronabinol and palmitoylethanolamide, suggesting it could significantly change the current treatment landscape for TS. The commencement of this clinical trial marks the result of extensive efforts by the SciSparc team and collaborating researchers.

The phase IIb trial will take place at three prestigious institutions: the Yale Child Study Center at the Yale School of Medicine in Connecticut, USA; Hannover Medical School in Hannover, Germany; and Tel Aviv Sourasky Medical Center in Israel. SciSparc has already obtained approval from the Institutional Review Boards of all three sites, as well as the Israeli Ministry of Health and the Federal Institute for Drugs and Medical Devices in Germany.

The trial’s primary goals are to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged between 18 and 65 years. Participants will receive daily oral treatments and will be randomized in a 1:1 ratio to receive either SCI-110 or a placebo. The main efficacy objective is to measure changes in tic severity using the Yale Global Tic Severity Scale at weeks 12 and 26 of the double-blind phase, compared to baseline. Additionally, the trial will monitor the absolute and relative frequencies of serious adverse events across the entire participant group and within the SCI-110 and placebo groups separately.

SciSparc Ltd. is driven by a seasoned team of senior executives and scientists. The company focuses on developing and enhancing a portfolio of cannabinoid-based pharmaceutical technologies. Current drug development programs include SCI-110 for TS and Alzheimer's disease with agitation, and SCI-210 for Autism Spectrum Disorder (ASD) and status epilepticus. Additionally, SciSparc holds a controlling interest in a subsidiary that sells hemp seed oil-based products on Amazon.com.

By advancing SCI-110 to the next phase of clinical trials, SciSparc aims to provide new hope for those suffering from TS, potentially offering an innovative treatment that addresses both efficacy and safety concerns. The company's strategic partnerships with leading research institutions further bolster the credibility and potential impact of their therapeutic solutions. As the trial progresses, SciSparc remains committed to its goal of transforming how disorders of the central nervous system are treated, leveraging cannabinoid pharmaceuticals.