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 at Hannover Medical School in Hanover, Germany, for SCI-110, a proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults. This move advances the global development program for SCI-110 following regulatory clearance from Germany’s Federal Institute for Drugs and Medical Devices and the ethics committee at Hannover Medical School.
The trial is a randomized, double-blind, placebo-controlled, cross-over study designed to evaluate the efficacy, safety, and tolerability of daily oral SCI-110 in patients aged 18-65. 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. Safety will be assessed through monitoring of adverse events. This Phase IIb study builds on positive results from the Phase IIa study, which demonstrated an average tic reduction of 21% across participants as measured by the gold-standard scale.
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.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera Labs, commented: “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. We are committed to advancing this promising therapy and delivering meaningful data to support its future approval.”
NeuroThera Labs Inc. 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 shares trade on the TSX Venture Exchange under the symbol NTLX.
This news release contains forward-looking information within the meaning of applicable Canadian securities legislation, including statements regarding the conduct, progress, and expected timing of the Phase IIb clinical trial; anticipated participation of additional clinical trial sites; patient enrollment; and the potential of SCI-110 to offer a novel or safer alternative. The company does not undertake any obligation to update or revise any forward-looking information, except as required by applicable securities laws.
For further information, contact Michal Efraty, IR Manager, at +972-3-7617108 or michal@efraty.com. View the original release on www.newmediawire.com.
