The trial aims to assess the safety, efficacy, and tolerability of daily oral doses of SCI-110 in adults aged between 18 and 65 years. Credit: sergey kolesnikov/Shutterstock.

Israel-based pharma company SciSparc has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for its Phase IIb clinical trial of its drug candidate SCI-110 to treat Tourette Syndrome (TS).

On receipt of approval, the trial is set to take place at three centres: the Yale Child Study Center at Yale School of Medicine, the Hannover Medical School, and the Tel Aviv Sourasky Medical Center.

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Institutional Review Board approvals have been obtained from all sites, alongside necessary approvals from the Israeli Ministry of Health and the Federal Institute for Drugs and Medical Devices in Germany.

This trial aims to assess the safety, efficacy, and tolerability of daily oral doses of SCI-110 in adults aged between 18 and 65 years. Participants will be randomly assigned into a 1:1 ratio to receive either SCI-110 or a matched placebo.

The primary efficacy endpoint will be the change in tic severity at weeks 12 and 26 compared to baseline.

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The safety of SCI-110 will also be assessed, with a focus on the frequency of serious adverse events in the overall population and in the groups receiving SCI-110 and placebo separately.

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SciSparc CEO Oz Adler said: “SciSparc is in a unique position to address the challenges associated with current TS treatments.

“We believe that our proprietary SCI-110, comprised of dronabinol and palmitoylethanolamide, has the potential to revolutionize the way TS is treated. Commencing the clinical trial is the culmination of diligent work by the SciSparc team, together with leading researchers in the field.”

In March this year, the company kicked off a trial evaluating its SCI-210 compound in children and adolescents with autism spectrum disorder (ASD).