NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., announced the initiation 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 trial is now progressing at the Yale Child Study Center, one of the study's key clinical sites. SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in a single, innovative dosage form designed to reduce tics and associated comorbid symptoms in adults with TS while aiming to minimize side effects. In addition to the Yale site, the Phase IIb trial is also underway at Hannover Medical School in Hanover, Germany, and Tel Aviv Sourasky Medical Center in Tel Aviv, 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. We are deeply committed to advancing this promising therapy and generating meaningful clinical data to support its future regulatory approval."
Building on the positive safety and efficacy results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participants sample, as measured by the gold standard, Yale Global Tic Severity Scale Total Tic Score, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial 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 initiation of this U.S. site is a significant step forward in the development of SCI-110, which could offer a new treatment option for adults with Tourette Syndrome. Current therapies for TS are often limited in effectiveness and can carry undesirable side effects, leaving many patients without adequate relief. If successful, SCI-110 could address this gap by providing a novel, potentially safer, and more effective treatment.
The expansion of the trial to multiple international sites underscores the global effort to bring this therapy to patients. With sites in Germany, Israel, and now the United States, the trial aims to gather robust data across diverse populations, which could support future regulatory submissions. The results of this Phase IIb study will be critical in determining the future of SCI-110 and its potential to become a standard of care for Tourette Syndrome.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations. The company's commitment to advancing SCI-110 reflects its mission to address unmet medical needs and improve the lives of patients suffering from debilitating conditions.
