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.
This milestone comes as the trial expands to key clinical sites globally, including Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel. The Phase IIb trial is a randomized, double-blind, placebo-controlled, cross-over study designed to assess the efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18 to 65. The primary endpoint is the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline.
SCI-110 combines dronabinol with palmitoylethanolamide (an endocannabinoid-like compound) in a single dosage form, aiming to reduce tics and comorbid symptoms while minimizing side effects. This approach builds on positive Phase IIa results, which demonstrated an average tic reduction of 21% across the participant sample, as measured by the gold-standard Yale Global Tic Severity Scale Total Tic Score.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, emphasized the importance of this development: “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 initiation of this trial is crucial for the Tourette Syndrome community, as current treatments are often inadequate or come with significant side effects. If successful, SCI-110 could offer a new therapeutic option for adults suffering from this chronic neurological disorder, which is characterized by involuntary motor and vocal tics. The condition can significantly impact quality of life, social interactions, and daily functioning.
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 committed to advancing SCI-110 through rigorous clinical development to support future regulatory approval. This trial represents a critical step toward potentially bringing a new treatment to patients who have limited options.
The expansion of the trial to multiple international sites underscores the global effort to address Tourette Syndrome. With the Yale site now active, the study is well-positioned to enroll participants and gather data that could inform the future of TS treatment. As the trial progresses, the company will continue to monitor safety and efficacy outcomes, with the hope of providing a meaningful improvement in the lives of those affected by this challenging condition.
