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 the Yale site marks a significant expansion of the trial, which is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel. SCI-110 combines dronabinol with palmitoylethanolamide in a single dosage form designed to reduce tics and associated comorbid symptoms while aiming to minimize side effects.
Tourette Syndrome is a neurological disorder characterized by involuntary tics, which can be severe and debilitating. Current treatment options are limited, and many patients do not respond adequately to existing therapies. The need for new, more effective treatments is particularly acute in adults, who often continue to experience persistent symptoms.
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 trial is a randomized, double-blind, placebo-controlled, cross-over study designed to evaluate the efficacy, safety, and tolerability of daily oral SCI-110. It builds on the positive results from the Phase IIa study, which demonstrated an average tic reduction of 21% across the entire participant sample, as measured by the Yale Global Tic Severity Scale Total Tic Score, a gold standard assessment tool.
Patients aged 18 to 65 will be randomized to receive either SCI-110 or placebo. The primary efficacy endpoint is the change in tic severity from baseline to weeks 12 and 26, as measured by the Yale Global Tic Severity Scale. Safety will be assessed through ongoing monitoring of adverse events.
The expansion to a U.S. site is particularly notable given the regulatory environment. The U.S. Food and Drug Administration (FDA) has shown interest in developing treatments for Tourette Syndrome, and having a prominent academic institution like Yale involved may help accelerate the drug’s development and eventual approval.
This development is important because it brings a potential new treatment for TS closer to patients. If successful, SCI-110 could offer a novel therapeutic option that not only reduces tics but also improves the quality of life for adults living with this challenging condition. The trial’s progress will be closely watched by the medical community and patient advocacy groups.
NeuroThera Labs is focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions. The company’s commitment to advancing SCI-110 through rigorous clinical testing reflects its dedication to addressing unmet medical needs.
The announcement also underscores the growing interest in cannabinoid-based therapies for neurological disorders. Dronabinol, a synthetic form of THC, has been studied for various conditions, and its combination with palmitoylethanolamide, an endocannabinoid-like compound, may enhance efficacy while reducing side effects.
As the trial progresses, the results will be critical in determining whether SCI-110 can become a viable treatment option. The collaboration with Yale, a leading institution in child and adolescent psychiatry, adds credibility to the study and may facilitate future research.
For more information about NeuroThera Labs and its pipeline, visit the company’s website at www.neurotheralabs.com.
