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 Germany for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults. 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 single dosage form designed to reduce tics and comorbid symptoms in adults with TS while minimizing side effects. The Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial that will evaluate the efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18-65. The primary efficacy endpoint is the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline.
The trial builds on positive results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participant sample, as measured by the gold-standard Yale Global Tic Severity Scale Total Tic Score. In addition to Hannover Medical School, the Phase IIb trial will be conducted at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.
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.”
The news is significant because Tourette Syndrome affects millions worldwide, yet approved treatments are scarce, especially for adults. Current therapies often come with significant side effects or limited efficacy. If SCI-110 proves successful in this Phase IIb trial, it could provide a new, well-tolerated option for patients who have few alternatives. The inclusion of multiple international sites—in Germany, the United States, and Israel—underscores the global scope of the development program and the potential for broad regulatory approvals.
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. The company is advancing SCI-110 with the goal of delivering meaningful data to support its future approval. The initiation of this trial at Hannover Medical School brings that goal one step closer, offering hope to patients and clinicians alike.
