NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and 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. This development marks a significant step in addressing the unmet medical needs of adults with TS, who often face persistent and debilitating symptoms with limited effective treatment options.
The trial had 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 oral dosage form designed to reduce tics and comorbid symptoms while minimizing side effects. In addition to Hannover Medical School, 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 participants as measured by the gold-standard Yale Global Tic Severity Scale Total Tic Score, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial. Patients aged 18-65 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 advancement to Phase IIb underscores NeuroThera Labs' dedication to developing novel therapeutics for central nervous system disorders. The implications of this trial are significant: if successful, SCI-110 could provide a new treatment paradigm for TS, a condition that currently lacks approved therapies specifically for adults. The global trial design, involving top-tier institutions in Germany, the United States, and Israel, enhances the robustness of the data and potential for regulatory acceptance. This news is important for patients, healthcare providers, and investors as it addresses a clear gap in the treatment landscape and represents progress in cannabinoid-based medicine for neurological disorders.
