SciSparc Ltd. (SPRC), a clinical-stage pharmaceutical company focused on developing cannabinoid-based treatments, has achieved a significant milestone in its quest to address unmet medical needs for Tourette Syndrome (TS). The U.S. Food and Drug Administration (FDA) has granted approval for the company’s Investigational New Drug (IND) application, paving the way for a Phase IIb clinical trial of their drug candidate, SCI-110.
Tourette Syndrome is a complex neurological disorder that primarily affects children and adolescents. Existing treatments often fail to effectively manage the symptoms, leading to a significant unmet need for more effective and safe therapies. SciSparc’s CEO, Oz Adler, highlighted this need, stating, “As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, we believe there is a clear unmet medical need for the management of TS.”
SCI-110 has shown promising results in previous trials. A Phase IIa clinical trial conducted at Yale University demonstrated a reduction in TS-related tics of 21% across patients, with nearly 40% experiencing a reduction of over 25%. Building on these encouraging results, the upcoming Phase IIb trial will take place at three prominent medical institutions: the Yale Child Study Center in Connecticut, the Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. This trial will focus on evaluating the efficacy, safety, and tolerability of SCI-110 in adult patients.
The trial will involve randomizing participants in a 1:1 ratio to receive either SCI-110 or a placebo. The primary safety objective is to assess serious adverse events across the patient population. The trial will measure changes in tic severity using the Yale Global Tic Severity Scale at weeks 12 and 26. Adler emphasizes the importance of a favorable safety profile for the therapy, stating, “The therapy of choice should also have a favorable safety profile, allowing for high patient drug compliance.”
SciSparc’s focus extends beyond TS, with the company exploring the potential of SCI-110 for treating other neurological disorders like Alzheimer’s disease and agitation. Adler expressed confidence in SCI-110’s potential to become the desired therapy, stating, “We believe our innovative drug candidate SCI-110 has the potential to be this desired therapy.”
This FDA approval marks a significant step forward for SciSparc and holds promise for individuals living with Tourette Syndrome. The upcoming Phase IIb trial represents a crucial stage in evaluating the potential of SCI-110 to address the unmet medical need for effective and safe treatment options.
