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.
SCI-110 combines dronabinol with palmitoylethanolamide in a single, innovative dosage form designed to reduce tics and associated comorbid symptoms while aiming to minimize side effects. The Phase IIb trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel, making this a global development program.
The initiation of the U.S. site marks a significant milestone in the development of SCI-110, which has the potential to address a major unmet medical need. Tourette Syndrome is a neurodevelopmental disorder characterized by involuntary tics, and current treatment options are limited, particularly for adults with persistent and debilitating symptoms. Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, emphasized that SCI-110 could offer a novel, more effective, and safer treatment approach.
The Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial 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. 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 adverse event monitoring.
This trial builds on positive results from the Phase IIa study, which showed an average tic reduction of 21% across participants, as measured by the gold-standard Yale Global Tic Severity Scale Total Tic Score. The new trial aims to further validate these findings and generate robust clinical data to support regulatory approval.
The launch of this trial at a prestigious institution like Yale underscores the potential significance of SCI-110 in the treatment of Tourette Syndrome. If successful, it could provide a new therapeutic option for patients who have limited choices and improve their quality of life. The global nature of the trial also ensures diverse patient populations and strengthens the generalizability of the results.
NeuroThera Labs is committed to advancing this promising therapy, and the initiation of the Phase IIb trial at Yale is a critical step forward. The company's dedication to developing novel treatments for central nervous system disorders is evident in this milestone, which brings hope to those affected by Tourette Syndrome.
