NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., has 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 had previously received regulatory clearance from Germany’s Federal Institute for Drugs and Medical Devices and the ethics committee of Hannover Medical School (MHH).
SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in an innovative single dosage form designed to reduce tics and comorbid symptoms in adults with TS while minimizing side effects. In addition to the German site, 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.
Building on positive safety and efficacy results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participant sample as measured by the Yale Global Tic Severity Scale Total Tic Score, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial. Patients aged 18 to 65 will be randomized to receive either SCI-110 or placebo, with the primary efficacy endpoint being 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.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera Labs, commented: “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.”
Tourette Syndrome affects approximately 0.5% of the global population, with many adults experiencing significant impairment from tics and comorbid conditions such as obsessive-compulsive disorder and anxiety. Current pharmacological options often have limited efficacy and undesirable side effects, highlighting the need for innovative therapies. The initiation of the Phase IIb trial at Hannover Medical School represents a critical milestone in the development of SCI-110, which could potentially fill this therapeutic gap.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations. For further information, contact Michal Efraty, IR Manager, at +972-3-7617108 or michal@efraty.com.
Neither the TSXV nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release. This news release contains forward-looking information within the meaning of applicable Canadian securities legislation, including statements regarding the conduct, progress and expected timing of the Phase IIb clinical trial, patient enrollment, the evaluation of SCI-110's efficacy and safety, and the potential for regulatory approval. Such forward-looking information involves known and unknown risks and uncertainties, including risks related to clinical development, regulatory approvals, and financing. The Company does not undertake any obligation to update such information except as required by law.
