NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., has announced the initiation of its Phase IIb clinical trial site at the Yale Child Study Center, Yale School of Medicine, in New Haven, Connecticut. The study, led by Dr. Michael H. Bloch, will evaluate SCI-110, the company's proprietary cannabinoid-based drug candidate for the treatment of Tourette Syndrome (TS) in adults.
The trial is now underway at Yale, one of the key clinical sites, and is also active at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel. SCI-110 combines dronabinol with palmitoylethanolamide, an endocannabinoid-like compound, in a single dosage form designed to reduce tics and comorbid symptoms while aiming to minimize side effects.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, emphasized the significance of the U.S. site: "Launching a U.S. site at the Yale Child Study Center represents a significant milestone in our global development program for SCI-110. TS remains a major unmet medical need with limited therapeutic options, particularly in adults who continue to experience persistent, severe, and often debilitating symptoms. We believe SCI-110 has the potential to introduce a novel, more effective and safer treatment approach."
The Phase IIb trial builds on positive results from the Phase IIa study, which showed an average tic reduction of 21% across participants, as measured by the Yale Global Tic Severity Scale Total Tic Score. The current study is a randomized, double-blind, placebo-controlled, cross-over trial designed to evaluate efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18-65. The primary endpoint is the change in tic severity from baseline to weeks 12 and 26, with safety monitored through adverse event reporting.
Tourette Syndrome is a neurological disorder characterized by involuntary tics, and while some treatments exist, they often have limited efficacy or significant side effects. The initiation of this trial at a prestigious institution like Yale underscores the potential impact of SCI-110. If successful, it could offer a new therapeutic option for adults with TS who have not responded to existing treatments.
For the broader industry, this trial represents a step forward in cannabinoid-based therapies for CNS disorders. NeuroThera's approach, combining dronabinol with palmitoylethanolamide, may set a precedent for future drug development in this area. The collaboration with leading academic centers like Yale also highlights the importance of clinical research in advancing care for neurological conditions.
As the trial progresses, results will be crucial in determining the future of SCI-110. The company remains committed to generating meaningful clinical data to support regulatory approval, offering hope to those affected by TS.
