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 Hannover Medical School in Germany for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome in adults. The trial previously received regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices and the ethics committee at Hannover Medical School.
SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in a single dosage form designed to reduce tics and comorbid symptoms in adults with Tourette Syndrome while minimizing side effects. The Phase IIb trial is a randomized, double-blind, placebo-controlled, cross-over study evaluating efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18 to 65. The primary efficacy endpoint is the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline.
Building on positive results from the Phase IIa study, which demonstrated an average tic reduction of 21% across participants, this next-phase trial aims to further validate the treatment. In addition to Hannover Medical School, the trial will be conducted at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera Labs, stated: 'The initiation of the German site marks an important step forward in our global development program for SCI-110. Tourette Syndrome is an unmet medical need condition with limited treatment options, particularly in adults who experience persistent, severe, and debilitating symptoms. We believe SCI-110 has the potential to offer a novel, more effective and safer alternative.'
The announcement highlights the growing interest in cannabinoid-based therapies for neurological disorders. Tourette Syndrome affects approximately 1% of the population, with many adults lacking adequate treatment options. If successful, SCI-110 could provide a new therapeutic avenue for patients who do not respond to existing medications or experience intolerable side effects.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders. For more information, visit the company's news release on NewMediaWire.
