NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., has announced the launch of its Phase IIb clinical trial site at the Yale Child Study Center, Yale School of Medicine, in New Haven, Connecticut. This marks a significant step in the global development of SCI-110, the company's proprietary cannabinoid-based drug candidate for the treatment of Tourette Syndrome (TS) in adults.
The trial, led by Dr. Michael H. Bloch at Yale, is one of several key sites evaluating SCI-110, which combines dronabinol with palmitoylethanolamide in a single dosage form designed to reduce tics and associated comorbid symptoms while minimizing side effects. Alongside the Yale site, the trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, emphasized the importance of the U.S. 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 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 Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial that builds on positive results from the Phase IIa study, which showed an average tic reduction of 21% across participants, measured by the Yale Global Tic Severity Scale Total Tic Score. The new trial will evaluate the efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18-65, with the primary endpoint being the change in tic severity from baseline to weeks 12 and 26.
The initiation of this trial is particularly important because Tourette Syndrome remains a challenging neurological disorder with limited treatment options, especially for adults. Current therapies often come with significant side effects, leaving many patients without adequate relief. SCI-110's unique combination of dronabinol and palmitoylethanolamide aims to offer a more effective and safer alternative, potentially improving the quality of life for those affected.
NeuroThera's commitment to advancing this therapy is underscored by its ongoing global trials, which will provide essential clinical data to support future regulatory approval. The company's focus on central nervous system disorders and underserved health conditions highlights the potential impact of this research on the broader medical community.
As the trial progresses, the results will be closely watched by the medical and scientific community. If successful, SCI-110 could become a first-of-its-kind treatment for Tourette Syndrome, addressing a critical gap in current therapeutic options. The collaboration with prestigious institutions like Yale further strengthens the credibility and potential of this research.
For more information about NeuroThera Labs and its pipeline, visit NewMediaWire.
