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, 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.
SCI-110 combines dronabinol with palmitoylethanolamide, an endocannabinoid-like compound, in a single dosage form designed to reduce tics and associated comorbid symptoms in adults with TS 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 efficacy endpoint is the change in tic severity as measured by the Yale Global Tic Severity Scale Total Tic Score at weeks 12 and 26 compared to baseline.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, stated, "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."
This expansion builds on the positive results from the Phase IIa study, which showed an average tic reduction of 21% across the participant sample, as measured by the gold-standard Yale Global Tic Severity Scale. The trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel, making it a global effort to address this condition.
The importance of this announcement lies in the potential of SCI-110 to fill a critical gap in Tourette Syndrome treatment. Current therapies often have limited efficacy or significant side effects, leaving many adults with persistent symptoms that severely impact quality of life. If successful, this trial could lead to a new, more effective and safer option for patients who have exhausted existing treatments.
According to the U.S. Centers for Disease Control and Prevention, Tourette Syndrome affects an estimated 1 in 162 children, and many continue to experience symptoms into adulthood. The condition is often associated with comorbid conditions such as obsessive-compulsive disorder and attention-deficit/hyperactivity disorder, further complicating treatment. The development of SCI-110 represents a novel approach that leverages the endocannabinoid system, which may offer a more targeted mechanism of action.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations. The company's commitment to advancing SCI-110 is underscored by its ongoing global clinical program, which aims to generate meaningful data to support regulatory approval.
The initiation of the Yale site is a key step in the Phase IIb trial, and the results are eagerly awaited by the medical community and patient advocacy groups. If the trial meets its endpoints, SCI-110 could become a first-in-class treatment for Tourette Syndrome, offering hope to millions of patients worldwide.
