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 in Hanover, Germany, for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults. This milestone advances the global development program for a condition with limited treatment options, particularly for adults suffering from persistent and severe symptoms.
The trial, which previously received regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices and Hannover Medical School's ethics committee, is now progressing at one of its key clinical sites. 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. 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 positive safety and efficacy results from the Phase IIa study, which demonstrated 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, 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 in patients aged 18 to 65. Participants 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 announcement lies in the potential for SCI-110 to address a significant gap in TS treatment. Current therapies often have limited efficacy or undesirable side effects, leaving many patients without adequate relief. The initiation of this Phase IIb trial at a prestigious institution like Hannover Medical School underscores the scientific community's interest in exploring cannabinoid-based approaches for neurological disorders. The inclusion of multiple international sites—including Yale Child Study Center and Tel Aviv Sourasky Medical Center—further strengthens the trial's design and generalizability.
If successful, SCI-110 could become a first-line treatment for adults with TS, offering a safer and more effective option. The trial's results are eagerly awaited by patients, clinicians, and investors alike, as they could pave the way for regulatory approval and commercialization. For more information about NeuroThera Labs, visit the original release at NewMediaWire.
