NeuroThera Labs Inc. Achieves Key Milestones for Tourette Syndrome Clinical Trial

October 22, 2026 — Leads & Copy — NeuroThera Labs Inc., a clinical-stage pharmaceutical company and a subsidiary of SciSparc Ltd., has announced significant progress in its U.S. Food and Drug Administration approved clinical trial program for SCI-110, a drug candidate being evaluated for the treatment of Tourette Syndrome (TS) in adults.

The company has successfully completed the manufacturing of the investigational product. This milestone was solidified by obtaining the necessary batch release certification from a European Qualified Person (QP), a crucial regulatory step that permits the shipment of clinical trial material to participating study sites. This certification is essential for initiating site activation activities and proceeding with patient enrollment in the FDA-approved Phase IIb clinical trial for TS.

The Phase IIb clinical trial is set to take place at three prominent clinical centers: the 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 designated sites have finalized their initiation procedures and are prepared to receive the clinical trial drug supplies following the QP batch release.

The completion of site initiation across all participating clinical centers, coupled with the successful European QP release of clinical trial supplies, represents a major operational achievement for NeuroThera. The company is now focused on advancing towards patient enrollment in its Phase IIb clinical trial for TS. Shipments of the investigational product to the study sites are anticipated in the near future.

SCI-110 is NeuroThera's proprietary drug candidate, protected by patents, which utilizes a cannabinoid-based formulation. It combines dronabinol and palmitoylethanolamide (PEA) in a single oral dosage form. The Phase IIb study is designed to assess the efficacy, safety, and tolerability of SCI-110 in adults diagnosed with TS, a condition characterized by significant unmet treatment needs.

NeuroThera Labs Inc. is a clinical-stage pharmaceutical company dedicated to developing innovative therapeutics for central nervous system disorders and other health conditions with limited treatment options. The company pursues its goals through strategic collaborations and the development of novel combination therapies.

Source: NeuroThera Labs Inc.