NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., 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, 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 this U.S. site marks a significant expansion of the global development program for SCI-110, which combines dronabinol with palmitoylethanolamide in a single dosage form. The therapy is designed to reduce tics and associated comorbid symptoms while aiming to minimize side effects, addressing a major unmet need in a condition where current treatments are limited and often inadequate.
“Launching a U.S. site at the Yale Child Study Center represents a significant milestone in our global development program for SCI-110,” said Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera. “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 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 adults aged 18 to 65. The primary endpoint is the change in tic severity from baseline to weeks 12 and 26, measured by the Yale Global Tic Severity Scale Total Tic Score, the gold standard for assessing tics. Safety will be monitored through adverse event reporting.
This trial builds on positive results from the Phase IIa study, which demonstrated an average tic reduction of 21% across all participants. The Phase IIb trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel, providing a multi-center approach to robust data collection.
The importance of this trial lies in its potential to offer a new therapeutic option for Tourette Syndrome, a neurodevelopmental disorder characterized by involuntary movements and vocalizations. Current treatments, including antipsychotics and behavioral therapy, are often limited by side effects or insufficient efficacy. If successful, SCI-110 could provide a novel mechanism of action that addresses both tics and comorbid conditions, such as anxiety and depression, which are common in TS patients.
NeuroThera Labs is dedicated to developing novel therapeutics for central nervous system disorders and other underserved health conditions. The company’s focus on innovative combinations and collaborations highlights its commitment to addressing significant medical gaps. The initiation of the Yale site underscores the potential of SCI-110 to make a meaningful difference in the lives of those affected by Tourette Syndrome.
For further information, contact Michal Efraty, IR Manager, at +972-3-7617108 or michal@efraty.com. This news release contains forward-looking statements regarding the potential benefits of SCI-110, which are subject to risks and uncertainties as described in the company’s continuous disclosure documents on SEDAR+ (www.sedarplus.ca). The company does not undertake to update these statements except as required by law.
