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, New Haven, Connecticut. The trial will evaluate SCI-110, the company’s proprietary cannabinoid-based drug candidate, for the treatment of Tourette Syndrome (TS) in adults. The study is led by Dr. Michael H. Bloch at Yale, one of the key clinical sites for the trial.
SCI-110 combines dronabinol with palmitoylethanolamide, an endocannabinoid-like compound, in a single dosage form. The drug aims to reduce tics and associated comorbid symptoms in adults with TS while minimizing side effects. The Phase IIb trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel, making it a global development program.
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 Phase IIb study builds on positive results from the Phase IIa trial, which showed an average tic reduction of 21% across participants, as measured by the Yale Global Tic Severity Scale Total Tic Score. The current trial is a randomized, double-blind, placebo-controlled, cross-over study 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, with the primary efficacy endpoint being the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. Safety will be assessed through monitoring of adverse events.
The importance of this trial lies in the significant unmet medical need for Tourette Syndrome treatments. Current therapeutic options are limited, and many adults with TS continue to experience severe and debilitating symptoms. SCI-110 offers a novel approach that could potentially provide a more effective and safer treatment option. If successful, this could lead to regulatory approval and offer new hope for patients suffering from TS.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions. The company is committed to advancing innovative treatments through collaborations and unique drug combinations. The initiation of this U.S. site marks a critical step in the global development of SCI-110, bringing the therapy closer to potential regulatory approval and clinical availability.
For more information about NeuroThera Labs and its clinical programs, visit the original release on NewMediaWire.
