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, 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 oral 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. It is designed to evaluate the efficacy, safety, and tolerability of daily oral SCI-110. 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.”
The initiation of this trial represents a significant milestone for NeuroThera Labs and the broader Tourette Syndrome community. With limited approved therapies for adults, SCI-110 could fill a critical gap if proven successful. The Phase IIb results will be pivotal in determining whether the drug can advance to Phase III trials and eventually reach the market. For business leaders and investors in the biotech sector, this development underscores the growing interest in cannabinoid-based therapeutics for central nervous system disorders. The global Tourette Syndrome treatment market, though niche, presents opportunities for innovative therapies that address safety and efficacy shortcomings of existing options.
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 in the press release highlight risks inherent in clinical development, including potential delays, regulatory hurdles, and the need for additional financing. However, the initiation of the Phase IIb trial at a prestigious institution like Hannover Medical School lends credibility to the program and may bolster investor confidence.
As the trial progresses, stakeholders will closely watch enrollment rates, safety data, and efficacy outcomes. If SCI-110 replicates or improves upon the 21% tic reduction seen in Phase IIa, it could represent a meaningful advance for patients. The company expects to report top-line data in due course, which will inform next steps in development and potential commercialization strategies.
