SciSparc receives FDA approval for a Phase IIb trial of a cannabinoid based treatment for Tourette Syndrome.
SciSparc Ltd., a clinical-stage pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND), which enables the company to proceed to Phase IIb clinical trial for its medication to treat Tourette Syndrome (TS).
This FDA approval is a significant milestone for the company as it seeks to address unmet medical needs in managing TS.
SciSparc Targets Unmet Medical
Tourette Syndrome is a complex neurological disorder that affects patients worldwide, especially children and adolescents. Existing treatments often fall short of effectively managing symptoms. "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," said SciSparc’s CEO, Oz Adler.
Global Clinical Trial To Start Soon
The upcoming Phase IIb trial will take place at three 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 assessing the efficacy, safety, and tolerability in adult patients. “The therapy of choice should also have a favorable safety profile, allowing for high patient drug compliance,” Adler added.
Participants in the trial will be randomized at a 1:1 ratio to receive either SCI-110 or a placebo. The trial will measure changes using the Yale Global Tic Severity Scale at weeks 12 and 26, with the primary safety objective being to assess serious adverse events across the patient population.
Cannabinoids And The Broader Vision
SciSparc is specialized in cannabinoid-based treatments for neurological disorders.
Besides SCI-110 for TS, the company is also exploring its potential for Alzheimer's disease and agitation. “We believe our innovative drug candidate SCI-110 has the potential to be this desired therapy,” Adler said.
