NeuroThera Labs Inc., a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., announced the initiation of its Phase IIb clinical trial site at Hannover Medical School in Hanover, Germany, for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults. The trial previously received regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices and the ethics committee of Hannover Medical School.
SCI-110 combines dronabinol with palmitoylethanolamide in a single dosage form designed to reduce tics and comorbid symptoms in adults with TS while minimizing side effects. The Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial that will evaluate the efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18 to 65. The primary efficacy endpoint is the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. Safety will be assessed through monitoring of adverse events.
In addition to Hannover Medical School, the trial will be conducted at the Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. The Phase IIb study builds on positive results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participant sample, as measured by the gold-standard Yale Global Tic Severity Scale Total Tic Score.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera Labs, stated: "The initiation of the German site marks an important step forward in our global development program for SCI-110. Tourette Syndrome is an unmet medical need condition with limited treatment options, particularly in adults who experience persistent, severe, and debilitating symptoms. We believe SCI-110 has the potential to offer a novel, more effective and safer alternative. We are committed to advancing this promising therapy and delivering meaningful data to support its future approval."
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions. The company's forward-looking statements regarding the trial's conduct, progress, and potential outcomes are subject to risks and uncertainties, including those related to clinical development, regulatory approvals, and financing. Additional information is available in the company's continuous disclosure documents filed on SEDAR+.
