Israeli pharmaceutical company SciSparc has received approval from the US Food and Drug Administration (FDA) to begin a Phase IIb clinical trial of SCI-110 in adults with Tourette syndrome.
The company filed an investigational new drug application seeking FDA clearance for the trial in August this year.
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The trial will be carried out at the Yale Child Study Center at the Yale School of Medicine in Connecticut, the Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel.
SciSparc has secured Institutional Review Board approvals for all sites, alongside necessary federal administration consents.
The trial’s primary goal is to assess the efficacy, safety and tolerability of daily oral doses of SCI-110 in adults aged 18 to 65 years.
Trial subjects will be randomised into a 1:1 ratio to receive either SCI-110 or a matched placebo.
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By GlobalDataThe trial’s main efficacy measure is evaluating the variation change in tic severity using the Yale Global Tic Severity Scale at weeks 12 and 26 of the double-blind phase compared to the baseline.
Its primary safety goal is to analyse the absolute and relative frequencies of serious adverse events among all trial subjects, as well as for the SCI-110 and placebo arms separately.
SciSparc CEO Oz Adler said: “As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, we believe there is a clear unmet medical need for the management of Tourette syndrome.
“In light of the results from our Phase IIa clinical trial conducted at Yale University that showed an average tic reduction of 21% across the entire sample with almost 40% of the patients experiencing greater than 25% in tic reduction, we believe that our innovative drug candidate SCI-110 has the potential to be this desired therapy.”
