NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., announced today 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 treating Tourette Syndrome (TS) in adults.
SCI-110 combines dronabinol with palmitoylethanolamide in a single dosage form designed to reduce tics and associated comorbid symptoms while aiming to minimize side effects. The Phase IIb trial is a randomized, double-blind, placebo-controlled, cross-over study that will assess the efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18-65. The primary endpoint is the change in tic severity measured by the Yale Global Tic Severity Scale (YGTSS) at weeks 12 and 26 compared to baseline.
This U.S. site is one of three global locations for the trial, which is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel. The initiation of the Yale site is a significant milestone, as the study builds on positive Phase IIa results that showed an average tic reduction of 21% across participants, as measured by the YGTSS Total Tic Score.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, emphasized the importance of this expansion: “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 trial’s progress at Yale is particularly noteworthy because TS is a neurodevelopmental disorder that often persists into adulthood, with current treatments offering limited efficacy and significant side effects. The potential of SCI-110 to address these gaps could have profound implications for the millions of people affected by TS worldwide. Moreover, the collaboration with the Yale Child Study Center, a leading institution in psychiatric research, lends credibility and expertise to the study.
For NeuroThera, this trial represents a critical step toward regulatory approval and commercialization. The company is focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions. The initiation of the Phase IIb trial at Yale underscores the company’s commitment to advancing SCI-110 and generating meaningful clinical data to support its future regulatory approval.
The announcement also highlights the growing interest in cannabinoid-based therapies for neurological conditions. While cannabis-derived compounds have shown promise in treating various disorders, rigorous clinical trials are needed to establish their safety and efficacy. NeuroThera’s approach, combining dronabinol with palmitoylethanolamide, may offer a unique mechanism of action that could differentiate it from other treatments.
As the trial progresses, the results will be closely watched by the medical community and investors alike. If successful, SCI-110 could become a first-of-its-kind treatment for Tourette Syndrome, offering new hope for patients who have not responded to existing therapies. The implications extend beyond TS, as the findings could also inform the development of other cannabinoid-based treatments for related conditions.
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 is listed on the TSXV under the symbol NTLX.
