NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., has 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.
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. The trial is now progressing at the Yale site, joining other key clinical sites 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."
The Phase IIb study builds on 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 new trial 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 trial at a prestigious institution like Yale underscores the potential significance of SCI-110 in the treatment of Tourette Syndrome. Tourette Syndrome is a neurological disorder characterized by repetitive, involuntary movements and vocalizations called tics. Current treatment options are limited and often associated with significant side effects, leaving many adults with persistent, severe symptoms. If successful, SCI-110 could offer a new, more effective and safer treatment option, potentially improving the quality of life for millions affected by this condition.
For the business and technology sectors, this development highlights the ongoing innovation in cannabinoid-based therapeutics and the importance of clinical research in addressing unmet medical needs. The progress of SCI-110 through clinical trials could pave the way for new treatments and open up commercial opportunities in the biotech industry. Moreover, the collaboration with leading academic institutions like Yale enhances the credibility and potential impact of the research.
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 dedication to bringing transformative treatments to patients.
