SciSparc Ltd. (SPRC) announced that its subsidiary, NeuroThera Labs Inc. (NTLX.V), a clinical-stage pharmaceutical company focused on developing treatments for central nervous system disorders, initiated its Phase IIb clinical trial site for SCI-110, its investigational candidate for the treatment of Tourette Syndrome (TS) in adults.
Tourette syndrome (TS) is a neurological disorder characterized by repeated, involuntary movements and vocalizations called tics. Tourette syndrome affects more boys than girls, and the first symptoms usually occur between the ages of 5 and 10 years, generally in the head and neck area. (Source: nih.gov)
SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in one dosage form designed to reduce tics and comorbid symptoms in adults with TS while minimising side effects.
The Phase IIb trial has commenced at Hannover Medical School, Hannover, Germany.
The Phase IIb study is a randomised, double-blind, placebo-controlled, cross-over trial designed to evaluate the efficacy, safety, and tolerability of daily oral SCI-110.
In the trial, patients aged 18 to 65 will be randomised to receive either SCI-110 or placebo. The primary efficacy endpoint is the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared with baseline.
According to the company, in the phase IIa study, SCI-110 demonstrated positive safety and efficacy results and showed an average tic reduction of 21% across all participants, as measured by the gold standard, Yale Global Tic Severity Scale Total Tic Score scale.
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".
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.
SPRC has traded between $2.98 and $80.10 over the last year. The stock closed Tuesday's trade at $4.27.
SPRC is currently up 1.41% at $4.33.
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