Dr. Adi Zuloff-Shani reports

NEUROTHERA LABS ANNOUNCES INITIATION OF PHASE IIB CLINICAL TRIAL AT HANNOVER MEDICAL SCHOOL IN GERMANY FOR INNOVATIVE TREATMENT OF TOURETTE SYNDROME

Neurothera Labs Inc. has initiated its phase IIb clinical trial site at Hannover Medical School, Hanover (MHH), 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 toward the next stage at Hannover Medical School, one of the key clinical sites of the study. SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in an innovative one 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, Conn., 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 per cent 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, crossover trial designed to evaluate the efficacy, safety and tolerability of daily oral SCI-110. Patients aged 18 to 65 will be randomized to receive either SCI-110 or placebo, with the primary efficacy end point being the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared with 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."

About Neurothera Labs Inc.

Neurothera 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.

We seek Safe Harbor.