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. 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 this U.S. site marks a significant milestone in the global development program for SCI-110, which combines dronabinol with palmitoylethanolamide in a single, innovative dosage form designed to reduce tics and associated comorbid symptoms while aiming to minimize side effects. 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, 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."
Building on positive results from the Phase IIa study, which showed an average tic reduction of 21% across participants as measured by the Yale Global Tic Severity Scale Total Tic Score, the Phase IIb trial is a randomized, double-blind, placebo-controlled, cross-over study. It will assess 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 at weeks 12 and 26 compared to baseline, with safety monitored through adverse event reporting.
The expansion to a prestigious U.S. institution like Yale underscores the potential significance of this treatment. Tourette Syndrome affects millions worldwide, and current therapies often provide inadequate relief or come with significant side effects. If successful, SCI-110 could offer a new, more effective option for adults suffering from this chronic condition.
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's forward-looking statements indicate a belief that SCI-110 has the potential to introduce a novel treatment approach, but actual results may differ due to risks and uncertainties outlined in its continuous disclosure documents on SEDAR+ (www.sedarplus.ca).
For further information, contact the company's IR manager at +972-3-7617108 or michal@efraty.com. Neither the TSXV nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.
