SciSparc Unit NeuroThera Labs Issues Update On Its Clinical Trial Program Evaluating SCI-110 For Treatment Of Tourette Syndrome In Adults; Now Advancing Toward Patient Enrollment In Its Phase IIb Clinical Trial For TS, With Investigational Product Shipments To Study Sites Expected In The Near Term

NeuroThera has successfully completed the manufacturing of the investigational product and obtained the required batch release certification from a European Qualified Person ("QP"), a key regulatory milestone authorizing shipment of clinical trial material to participating study sites. The release enables site activation activities and supports the initiation of patient enrollment in the FDA-approved Phase IIb clinical trial for TS.

The Phase IIb clinical trial is being conducted at three clinical sites: Yale Child Study Center at Yale School of Medicine in New Haven, Connecticut, USA; Hannover Medical School in Hanover, Germany; and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. All participating sites have successfully completed their site initiation activities and are prepared to receive clinical trial drug supplies following QP batch release.

Completion of site initiation activities across all participating clinical centers, together with the successful European QP release of clinical trial supplies, marks a significant operational milestone for NeuroThera, which is now advancing toward patient enrollment in its Phase IIb clinical trial for TS, with investigational product shipments to study sites expected in the near term.

SCI-110 is NeuroThera’s proprietary, patent-protected cannabinoid-based drug candidate, combining dronabinol and palmitoylethanolamide (PEA) in a single oral dosage form. The Phase IIb study is evaluating SCI-110's efficacy, safety and tolerability in adults with TS, a condition with substantial unmet treatment needs.