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 previously received regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices and MHH's ethics committee.
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 safety and efficacy results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participant sample 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. 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.
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. (TSXV: NTLX) 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. For further information, contact Michal Efraty, IR Manager, at telephone: +972-3-7617108 or email: michal@efraty.com. Neither the TSXV nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.
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 trial; anticipated participation of additional clinical trial sites; patient enrollment and randomization; evaluation of efficacy, safety, and tolerability; potential of SCI-110 to offer a novel or safer alternative; generation of data to support future regulatory approval; and continued development and potential commercialization. These statements involve known and unknown risks and uncertainties, such as inherent risks of clinical development, potential delays, patient recruitment challenges, reliance on third parties, regulatory hurdles, and need for additional financing. The Company does not undertake any obligation to update forward-looking information except as required by law. View the original release on NewMediaWire.
