SCI-110 is intended for the treatment of Tourette Syndrome. Credit: Gorodenkoff/Shutterstock.com.

SciSparc has initiated a Phase IIb clinical trial of its SCI-110 drug for the treatment of Tourette Syndrome (TS), a neurodevelopmental disorder.

The latest move is based on the encouraging results demonstrated in the prior Phase IIa study conducted at the Yale School of Medicine.

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The randomised, double-blind study will initially be carried out at the Tel Aviv Sourasky Medical Center (Sourasky) in Israel.

Later, the study is planned at the Hannover Medical School in Hannover, Germany and the Yale Child Study Center at the Yale School of Medicine in Connecticut, US.

SciSparc received the Institutional Review Board approvals from the three clinical centres for the initiation at their respective sites.

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The aim of the study is to assess the safety, tolerability, and efficacy of the proprietary drug candidate SCI-110 in adult patients with TS.

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Patients aged between 18 and 65 years will be randomised into 1:1 ratio to receive either oral SCI-110 or a SCI-110-matched placebo orally.

Assessing tic severity change, using the Yale Global Tic Severity Scale, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline is the primary efficacy objective of the study.

The study’s primary safety objective is to evaluate absolute and relative frequencies of serious adverse events for the complete population and, separately, for the both the treatment groups.

SciSparc CEO Oz Adler said: “This is an important area of growth for the company, alongside the company’s other proprietary platforms, including SCI-110 in patients with Alzheimer’s disease and agitation and SCI-210 for children suffering from autism spectrum disorder.”

Other drug development programmes of SciSparc based on THC and/or non-psychoactive cannabidiol include SCI-160 for the treatment of pain.