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 Hanover, Germany, for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults. The trial, which previously received regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices and MHH's ethics committee, is now advancing towards the next stage at one of the key clinical sites of the study.
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. In addition to Hannover Medical School, the trial will be conducted at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.
Building on the positive safety and efficacy results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participants sample as measured by the gold standard Yale Global Tic Severity Scale Total Tic Score scale, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial designed to evaluate the efficacy, safety, and tolerability of daily oral SCI-110. Patients aged 18-65 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 the 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.”
The initiation of this trial underscores the importance of addressing Tourette Syndrome, a neurological disorder characterized by involuntary tics that can significantly impair quality of life. Current treatment options are often limited by side effects or insufficient efficacy, highlighting the need for innovative therapies. SCI-110's unique formulation aims to provide a more targeted approach with fewer adverse effects, potentially filling a critical gap in the therapeutic landscape.
NeuroThera Labs continues to advance its clinical program, with the Phase IIb trial expected to generate pivotal data. The inclusion of multiple international sites enhances the robustness of the study and supports the generalizability of results. For further information, refer to the company's continuous disclosure documents filed on SEDAR+ (www.sedarplus.ca).
This news release contains forward-looking information within the meaning of applicable Canadian securities legislation, including statements regarding the conduct and expected timing of the trial, patient enrollment, and the potential of SCI-110. Such statements are subject to risks and uncertainties, including those related to clinical development, regulatory approvals, and financing. The company does not undertake to update these statements except as required by law.
