NeuroThera Labs Launches Phase IIb Trial at Yale for Tourette Syndrome Treatment

NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., has launched its Phase IIb clinical trial 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. This U.S. site is one of several key locations in the global development program, with trials also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel.

The initiation of this trial represents a significant milestone for NeuroThera and the broader medical community, as Tourette Syndrome remains a major unmet medical need with limited therapeutic options, particularly for adults who experience persistent and often debilitating symptoms. SCI-110 combines dronabinol with palmitoylethanolamide, an endocannabinoid-like compound, in a single innovative dosage form designed to reduce tics and associated comorbid symptoms while minimizing side effects. The drug candidate has already shown promise in a Phase IIa study, which demonstrated an average tic reduction of 21% across the entire participant sample, as measured by the Yale Global Tic Severity Scale Total Tic Score.

The Phase IIb trial is a randomized, double-blind, placebo-controlled, cross-over study designed to evaluate the efficacy, safety, and tolerability of daily oral SCI-110. 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 from baseline to weeks 12 and 26. Safety will be assessed through monitoring of adverse events. The inclusion of the Yale Child Study Center, a renowned institution for psychiatric research, underscores the credibility and potential impact of this investigation.

Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, commented: “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. We are deeply committed to advancing this promising therapy and generating meaningful clinical data to support its future regulatory approval.”

This development is not only crucial for individuals living with Tourette Syndrome but also for the biotechnology industry in Texas and beyond, as it highlights the ongoing efforts to innovate in central nervous system disorders. NeuroThera's focus on developing novel therapeutics through collaborations and innovative combinations aligns with the broader trend of advancing treatments for underserved health conditions. The progress of this trial could pave the way for a new standard of care, offering hope to patients who have long faced limited options.

The company's commitment to rigorous clinical evaluation is evident in its strategic selection of trial sites and its adherence to robust study designs. As the trial progresses, stakeholders will be watching closely for results that could further validate SCI-110's potential. For more information about NeuroThera Labs and its pipeline, interested parties can refer to the company's disclosures on SEDAR+.