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 towards the next stage at one of the key clinical sites of the study.
SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in an innovative 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 the positive safety and efficacy results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participants sample as measured by the gold standard Yale Global Tic Severity Scale Total Tic Score scale, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial designed to evaluate the 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 measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared to the 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, NeuroThera Labs Inc., Telephone: +972-3-7617108, 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 statements that constitute forward-looking information within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Forward-looking information includes, without limitation, statements regarding: the conduct, progress and expected timing of the Company's Phase IIb clinical trial of SCI-110; the anticipated participation of additional clinical trial sites; patient enrollment and randomization; the evaluation of efficacy, safety and tolerability; the potential of SCI-110 to offer a novel or safer alternative; the generation of data to support future regulatory approval; and the continued development and potential commercialization of SCI-110. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking information involves known and unknown risks and uncertainties, including the inherent risks of clinical development, such as delays or termination; risks related to patient recruitment; the possibility that trial results may not demonstrate efficacy or safety; reliance on third parties; regulatory hurdles; the need for additional financing; competition; and intellectual property risks. The Company does not undertake any obligation to update forward-looking information, except as required by law. View the original release on NewMediaWire.
