NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., has announced the launch 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. This marks a significant step in advancing a potential new therapy for a condition with limited treatment options.
SCI-110 combines dronabinol with palmitoylethanolamide in a single, innovative dosage form designed to reduce tics and associated comorbid symptoms in adults with TS while aiming to minimize side effects. The trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel, making it a global development program. The initiation of the U.S. site at Yale is particularly notable given the institution's expertise in TS research.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, emphasized the importance of this milestone: "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 study builds on the positive results from the 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 design 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, with safety assessed through monitoring of adverse events.
The implications of this trial are significant for the Tourette Syndrome community. Current treatments for TS are often limited and can have undesirable side effects. If SCI-110 proves effective, it could offer a new, more tolerable option for adults who have not found relief with existing therapies. The inclusion of a prestigious site like Yale adds credibility and may accelerate recruitment and data collection, potentially speeding up the path to regulatory approval.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions. The company's commitment to advancing SCI-110 reflects a broader effort to address the needs of patients with TS, a condition that affects millions worldwide but has seen few innovative treatments in recent years. As the trial progresses, the results will be closely watched by both the medical community and investors, given the potential market opportunity and the unmet need.
For more information, visit the original release at NewMediaWire.
