SciSparc has commenced the Investigational New Drug (IND) application process preparation for the Phase IIb Tourette Syndrome (TS) trial of its drug candidate, SCI-110, with the US Food and Drug Administration (FDA).
The company stated that the IND submission is intended to open a clinical site in the US that will include in the trial.
Containing Dronabinol, with the endocannabinoid palmitoylethanolamide (PEA), SCI-110 has been designed to stimulate cannabinoid receptors across the central nervous system and inhibit the metabolic degradation of endocannabinoids for improving THC uptake.
A Phase IIa trial, which was conducted at Yale University earlier, demonstrated that TS medication-refractory patients had 21% reduction of tic symptoms across the complete sample.
The company stated that improvement over time was also observed with the treatment using SCI-110 when generalised linear models were used to study the repeated measures data on the Yale Global Tic Severity Scale (YGTSS-TTS).
It is now advancing into a Phase IIb trial based on the positive results.
SciSparc chief technologies officer Dr Adi Zuloff-Shani said: “We are very excited about expanding our clinical sites to the US, especially after positive results obtained in a clinical trial led by professor Bloch, an associate professor in the Child Trial Center at Yale University, using our proprietary drug candidate.
“Expanding this trial, is part of our overall efforts to expedite the development of SCI-110 for TS, which is a greatly underserved therapeutic area.”
The multi-national, double-blind, randomised, multi-centre, placebo controlled cross-over Phase IIb trial has been designed to assess SCI-110’s tolerability, safety, and efficacy in TS adult patients.
In this trial, the participants will be randomised in a 1:1 ratio and given either SCI-110 or SCI-110 matched placebo.
The trial’s primary efficacy objective is to evaluate the tic severity change as a continuous endpoint at week 12 and 26 of the double-blind phase compared to the baseline.
The absolute and relative frequencies of serious adverse events will be evaluated for all the participants and separately for the SCI-110 and placebo groups as the trial’s primary safety objective.
Recently, the company obtained the Ethics Committee approval from the Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Israel.
These two will be the first two sites of the Phase IIb trial.