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 Hanover, Germany, for SCI-110, a 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 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, 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 importance of this trial lies in the significant unmet medical need for Tourette Syndrome treatments. Current options are limited, especially for adults, and often come with substantial side effects. If successful, SCI-110 could provide a novel therapeutic alternative that improves tic reduction and tolerability. The global development program, including sites in Germany, the United States, and Israel, underscores the widespread demand for better TS therapies. Positive results from this Phase IIb trial could pave the way for regulatory submissions and eventual commercialization, potentially transforming the treatment landscape for Tourette Syndrome.
For further information about NeuroThera Labs and its clinical programs, interested parties can refer to the company's continuous disclosure documents filed on SEDAR+.
This news release contains forward-looking information within the meaning of applicable Canadian securities legislation. Such statements involve known and unknown risks and uncertainties that may cause actual results to differ materially, including risks related to clinical development timelines, patient enrollment, regulatory approvals, and competition.
