NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., announced today that it has initiated 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.
The initiation of the Yale site is a key milestone in the global development program for SCI-110, which combines dronabinol with the endocannabinoid-like palmitoylethanolamide in a single, innovative dosage form. The drug aims to reduce tics and associated comorbid symptoms in adults with TS while minimizing side effects. In addition to the Yale site, the trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel.
Tourette Syndrome remains a major unmet medical need, with limited therapeutic options, particularly for adults who experience persistent, severe, and often debilitating symptoms. The current standard of care includes antipsychotic medications, which are often associated with significant side effects, and behavioral therapies, which may not be effective for all patients. There is a clear need for novel, more effective, and safer treatment approaches.
The Phase IIb trial is a randomized, double-blind, placebo-controlled, cross-over study designed to evaluate 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 measured by the Yale Global Tic Severity Scale (YGTSS) at weeks 12 and 26 compared to baseline. Safety will be assessed through monitoring of adverse events.
This trial builds on the positive results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participant sample, as measured by the YGTSS Total Tic Score. These encouraging findings support the further investigation of SCI-110 as a potential treatment for TS.
The initiation of the trial at Yale is particularly significant given the institution's reputation as a leading center for TS research and treatment. Dr. Michael H. Bloch, who leads the study at Yale, is a prominent researcher in the field of child psychiatry and has conducted extensive research on TS and its treatments. His involvement adds credibility and expertise to the trial.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, commented, "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. We are deeply committed to advancing this promising therapy and generating meaningful clinical data to support its future regulatory approval."
The implications of this announcement are substantial. If SCI-110 proves to be safe and effective in the Phase IIb trial, it could offer a new therapeutic option for the many adults with TS who have not found adequate relief from existing treatments. Moreover, the collaboration with prestigious academic institutions like Yale underscores the scientific credibility of the research and may facilitate future regulatory approvals and market adoption.
For more information about NeuroThera Labs, visit the company's profile on SEDAR+.
