NeuroThera Labs Inc., a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., has initiated a Phase IIb clinical trial site at the Yale Child Study Center, Yale School of Medicine, for its investigational drug SCI-110, a potential treatment for Tourette Syndrome (TS) in adults. The trial, led by Dr. Michael H. Bloch, marks a significant step in developing a new therapeutic option for a condition with limited treatments.
SCI-110 combines dronabinol with palmitoylethanolamide in a single dosage form, aiming to reduce tics and comorbid symptoms while minimizing side effects. The Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial enrolling adults aged 18-65. The primary endpoint is the change in tic severity as measured by the Yale Global Tic Severity Scale at weeks 12 and 26. 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 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 who continue to experience persistent, severe, and often debilitating symptoms." The Phase IIa study showed an average tic reduction of 21% across participants, supporting further investigation.
This development is crucial as Tourette Syndrome affects millions worldwide, and current treatments often have limited efficacy or significant side effects. If successful, SCI-110 could offer a novel, more effective, and safer treatment approach. The initiation of the U.S. site enhances the trial's global reach and potential to enroll a diverse patient population.
NeuroThera Labs focuses on developing therapeutics for central nervous system disorders and other underserved conditions. The company's commitment to advancing SCI-110 is evident in its ongoing clinical program. For more information about the trial, visit NewMediaWire.
