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, a proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) 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 an innovative single dosage form designed to reduce tics and comorbid symptoms in adults with TS while minimizing side effects. Building on positive Phase IIa results showing an average tic reduction of 21% as measured by the Yale Global Tic Severity Scale, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial enrolling patients aged 18-65. The primary efficacy endpoint is change in tic severity at weeks 12 and 26 compared to baseline, with safety assessed through adverse event monitoring.
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 underscores the importance of advancing therapies for TS, a condition affecting approximately 1% of the population, with limited pharmacological options. Current treatments often involve antipsychotics with significant side effects, highlighting the need for safer alternatives. SCI-110's mechanism aims to target the endocannabinoid system, which may modulate tic expression. The Phase IIb results will be critical for determining whether this approach can provide meaningful clinical benefit and support regulatory approval.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders. The company's forward-looking statements caution that clinical development involves risks, including potential delays, regulatory hurdles, and the need for additional financing. However, the initiation of this trial represents a key milestone in addressing the unmet needs of adults with Tourette Syndrome.
