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 (MHH) in Hanover, Germany, for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults.
The trial, which previously received regulatory clearance from Germany’s Federal Institute for Drugs and Medical Devices and MHH's ethics committee, is now advancing at one of the key clinical sites. SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in a single dosage form designed to reduce tics and comorbid symptoms in adults with TS while minimizing side effects.
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. Building on positive Phase IIa results, which showed an average tic reduction of 21% as measured by the Yale Global Tic Severity Scale Total Tic Score, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial evaluating 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 at weeks 12 and 26 compared to baseline. Safety will be assessed through monitoring of adverse events. 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.”
NeuroThera Labs Inc. is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions. The company is listed on the TSXV under the symbol NTLX. For further information, contact Michal Efraty, IR Manager, at +972-3-7617108 or michal@efraty.com.
This news release contains forward-looking information within the meaning of applicable Canadian securities legislation, including statements regarding the conduct and progress of the Phase IIb trial, patient enrollment, and the potential of SCI-110. These statements involve known and unknown risks and uncertainties, such as delays in clinical development, reliance on third parties, and regulatory challenges. The Company does not undertake to update any forward-looking information except as required by law. View the original release on NewMediaWire.
