NeuroThera Labs Inc. (TSXV: NTLX) 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. This U.S. site is part of a global development program for SCI-110, the company's proprietary cannabinoid-based drug candidate designed to treat Tourette Syndrome (TS) in adults.
The trial, led by Dr. Michael H. Bloch, will evaluate the efficacy and safety of SCI-110, which combines dronabinol with palmitoylethanolamide in a single dosage form. This innovative approach aims to reduce tics and comorbid symptoms in adults with TS while minimizing side effects. The Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial enrolling patients aged 18-65, with the primary endpoint being the change in tic severity as measured by the Yale Global Tic Severity Scale Total Tic Score at weeks 12 and 26.
This launch is a milestone for NeuroThera, as it expands the trial to a U.S. site, complementing ongoing activities at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel. The decision to include Yale is particularly significant given the center's reputation in child study and psychiatric research, and the trial's principal investigator, Dr. Bloch, is a leading expert in Tourette Syndrome.
The importance of this development lies in the substantial unmet medical need for effective TS treatments, especially for adults who often experience persistent and debilitating symptoms. Current therapeutic options are limited, and many patients do not respond adequately or suffer from adverse effects. SCI-110 builds on positive Phase IIa results, which demonstrated an average tic reduction of 21% across all participants, as measured by the same gold-standard scale. The Phase IIb trial aims to confirm and expand these findings in a larger, controlled setting.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, emphasized the significance of the Yale site, stating, "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." She added that the company believes SCI-110 has the potential to introduce a novel, more effective, and safer treatment approach, and is committed to generating meaningful clinical data to support future regulatory approval.
The initiation of this trial at Yale not only accelerates the development of a promising therapy but also underscores the collaborative effort between academic institutions and biotech companies to address complex neurological disorders. If successful, SCI-110 could offer a new treatment option for the millions of individuals affected by Tourette Syndrome worldwide.
