SciSparc has signed a clinical trial agreement with Yale University to add the Yale Child Study Center as a site for conducting the Phase IIb trial of SCI-110 to treat Tourette Syndrome (TS) patients.
Yale University represents the third medical centre to join the company’s randomised, multinational, double-blind, multi-centre, placebo-controlled cross-over Phase IIb trial.
The company previously added the Hannover Medical School in Germany and the Tel Aviv Sourasky Medical Center in Israel as trial sites of excellence for the clinical study.
Yale University Child Study Center associate professor Dr Michael Bloch will lead the trial, which is designed to assess the safety, tolerability, and efficacy of SCI-110 in TS adult patients aged between 18 and 65 years.
A Phase IIa trial, which was earlier carried out at Yale University, demonstrated that the TS medication-refractory patients had experienced a 21% reduction of tic symptoms across the complete sample.
Additionally, an improvement over time was observed with SCI-110 treatment when generalised linear models were used for analysing repeated measures data on the Yale Global Tic Severity Scale (YGTSS-R-TTS).
SciSparc chief technologies officer Dr Adi Zuloff-Shani said: “Importantly, this Phase IIb trial is a unified trial, as the trial’s data are expected to qualify for regulatory submissions with both the FDA (US Federal Drug Administration) and the EMA (European Medicines Agency).
“We look forward to further expanding this trial, as part of the overall team effort working to develop a treatment for this therapeutic area, which is greatly underserved, and we believe our approach has significant advantages over available treatments.”
Participants in the Phase IIb trial will be randomised in a 1:1 ratio and given either SCI-110 or a placebo.
The tic severity change evaluation using YGTSS-R-TTS as a continuous endpoint at weeks 12 and 26 of the double-blind phase compared to the baseline will be the trial’s primary efficacy objective.
The trial’s primary safety objective is to evaluate absolute and relative frequencies of serious adverse events for all participants and separately for the SCI-110 and placebo groups.
Last month, the company started the process of preparing for an Investigational New Drug Application (IND) for the Phase IIb trial with the FDA.