NeuroThera Labs Initiates Phase IIb Trial of Cannabinoid-Based SCI-110 for Tourette Syndrome at Hannover Medical School
核心洞察
NeuroThera Labs has launched a Phase IIb clinical trial site at Hannover Medical School in Germany for SCI-110, its cannabinoid-based treatment candidate for adult Tourette Syndrome (搜索).
The randomized, double-blind, placebo-controlled, cross-over trial will also enroll patients at Yale Child Study Center and Tel Aviv Sourasky Medical Center.
SCI-110 combines dronabinol with palmitoylethanolamide and previously demonstrated a 21% average tic reduction in the Phase IIa study as measured by the Yale Global Tic Severity Scale.
NeuroThera Labs Inc. (搜索) (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd. (Nasdaq: SPRC), announced on July 15, 2026 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 (搜索) (TS) in adults. The trial previously received regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices and MHH's ethics committee.
The study will also be conducted at two additional sites: the Yale Child Study Center in New Haven, Connecticut, and the Tel Aviv Sourasky Medical Center in Tel Aviv, Israel, establishing a multi-national clinical development program for the investigational therapy.
Trial Design and Endpoints
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 to 65 will be randomized to receive either SCI-110 or placebo. The primary efficacy endpoint is the change in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) Total Tic Score at weeks 12 and 26 compared to baseline. Safety will be assessed through monitoring of adverse events throughout the trial period.
Building on Phase IIa Results
The Phase IIb trial builds on positive safety and efficacy results from a prior Phase IIa study, which demonstrated an average tic reduction of 21% across the entire participant sample, as measured by the YGTSS, the gold standard assessment tool for tic severity. SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in a single dosage form, designed to reduce tics and comorbid symptoms in adults with TS while minimizing side effects.
Addressing Unmet Medical Need
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera Labs, emphasized the significance of the trial's advancement: "The initiation of the German site marks an important step forward in our global development program for SCI-110. Tourette Syndrome (搜索) 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."
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.