NeuroThera Labs Inc., a subsidiary of SciSparc Ltd., announced it has completed manufacturing of the investigational product for a Phase IIb clinical trial of SCI-110 for Tourette syndrome in adults and received batch release certification from a European Qualified Person, authorizing shipment of trial material to study sites.

The trial is being conducted at three sites: Yale Child Study Center at Yale School of Medicine in New Haven; Hannover Medical School in Hanover, Germany; and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. NeuroThera said all three have completed site initiation activities and are prepared to receive trial drug supplies.

NeuroThera described the completed site initiation and batch release as a significant operational milestone, and said the release enables site activation and supports the start of patient enrollment. The company describes the trial as approved by the U.S. Food and Drug Administration.

SCI-110, which NeuroThera describes as a proprietary, patent-protected cannabinoid-based drug candidate, combines dronabinol and palmitoylethanolamide in a single oral dosage form. The study is evaluating its efficacy, safety and tolerability in adults with Tourette syndrome, which the company says has substantial unmet treatment needs.  The company is now advancing toward patient enrollment, with investigational product shipments to the study sites expected in the near term.