NeuroThera Labs Launches Phase IIb Trial for Tourette Syndrome Treatment in Germany

NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage biotech company and majority-owned subsidiary of SciSparc Ltd., today announced the initiation of its Phase IIb clinical trial site at Hannover Medical School (MHH) in Germany for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults. This milestone follows 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 an innovative one dosage form designed to reduce tics and comorbid symptoms while minimizing side effects. The trial will also be conducted at Yale Child Study Center and Tel Aviv Sourasky Medical Center, making it a global effort to address an unmet medical need.

Building on positive Phase IIa results that showed an average tic reduction of 21% measured by the Yale Global Tic Severity Scale, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial. Patients aged 18-65 will receive daily oral SCI-110 or placebo, with the primary endpoint being change in tic severity at weeks 12 and 26. Safety will be monitored through adverse events. Dr. Adi Zuloff-Shani, CTO of NeuroThera Labs, emphasized that Tourette Syndrome has limited treatment options, especially for adults with persistent symptoms, and that SCI-110 has the potential to offer a novel, safer alternative. The company is committed to advancing this therapy and delivering data to support future approval.

NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders. The news release includes forward-looking statements and cautions that clinical development involves risks and uncertainties. For more details, see the original release on NEWMEDIAWIRE. The company encourages readers to review its continuous disclosure documents on www.sedarplus.ca for further information on risks.