NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and a majority-owned subsidiary of SciSparc Ltd., announced today 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 advancement of this trial is significant because Tourette Syndrome affects millions worldwide, yet treatment options remain limited, especially for adults. Current therapies often involve antipsychotic medications with significant side effects, leaving patients with few safe and effective alternatives. If successful, SCI-110 could provide a novel approach that reduces tics and comorbid symptoms while minimizing adverse effects, potentially improving quality of life for many patients. The inclusion of multiple international sites, including a top-tier center like Hannover Medical School, strengthens the study's design and increases the likelihood of robust, generalizable results.
This news matters because it represents progress in addressing a condition with high unmet need. The Phase IIb trial will provide crucial data on efficacy and safety, bringing SCI-110 closer to potential regulatory approval and commercialization. For the biotech industry, this underscores the growing interest in cannabinoid-based therapies for neurological disorders, a field that could open new treatment avenues. For patients and healthcare providers, the development of SCI-110 offers hope for a more targeted and tolerable therapy.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders. More information about the company and its forward-looking statements can be found in its continuous disclosure documents filed on SEDAR+.
