SciSparc Ltd., a clinical-stage pharmaceutical company, announced on September 23, 2024, that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application, allowing the company to proceed with Phase IIb clinical trials for its drug candidate SCI-110, aimed at treating Tourette Syndrome (TS) in adult patients. The trials will be conducted at three global leading centers, including the Yale Child Study Center in the U.S., Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. Institutional Review Board approvals have been secured for all sites. The trial will assess the efficacy, safety, and tolerability of SCI-110, with patients randomized to receive either the drug or a placebo. The primary efficacy...Show More

SciSparc Ltd., a clinical-stage pharmaceutical company, announced on September 23, 2024, that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application, allowing the company to proceed with Phase IIb clinical trials for its drug candidate SCI-110, aimed at treating Tourette Syndrome (TS) in adult patients. The trials will be conducted at three global leading centers, including the Yale Child Study Center in the U.S., Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. Institutional Review Board approvals have been secured for all sites. The trial will assess the efficacy, safety, and tolerability of SCI-110, with patients randomized to receive either the drug or a placebo. The primary efficacy measure will be the change in tic severity using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. SciSparc's CEO, Oz Adler, expressed confidence in the potential of SCI-110 to offer a novel treatment for TS, following swift FDA approval and positive results from the previous Phase IIa trial. SciSparc specializes in cannabinoid-based pharmaceuticals and is also engaged in drug development programs for Alzheimer's disease, agitation, Autism Spectrum Disorder (ASD), and status epilepticus.