NeuroThera Labs Inc. (TSXV: NTLX), 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 (MHH) in 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 MHH's ethics committee.
SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in an innovative one-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 evaluating efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18-65. 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.
Building on positive results from the Phase IIa study, which showed an average tic reduction of 21% across participants as measured by the gold-standard Yale Global Tic Severity Scale Total Tic Score, the Phase IIb trial will also be conducted at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.
“The initiation of the German site marks an important step forward in our global development program for SCI-110,” said Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera Labs. “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.”
The announcement underscores the importance of this trial for the Tourette Syndrome community. TS affects approximately 1 in 100 individuals, with many adults lacking effective therapies. Current treatments often have significant side effects or limited efficacy. SCI-110 aims to address this gap by combining two compounds that target the endocannabinoid system, which plays a role in tic regulation. The Phase IIa results, showing a 21% reduction in tics, suggest clinically meaningful improvement, and the Phase IIb trial will further assess its potential.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders. The company is advancing SCI-110 through global clinical development, with the goal of providing a new treatment option for TS patients. For more information, visit the company’s website at NeuroThera Labs.
Forward-looking statements in this release involve risks and uncertainties, including those related to clinical trial delays, regulatory approvals, and financing needs. The Company does not undertake any obligation to update forward-looking information except as required by law.
