SciSparc Ltd. (NASDAQ:SPRC), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, has started the process of preparing for an Investigational New Drug Application (“IND”) with the U.S. Food and Drug Administration for its Phase IIb clinical trial for SCI-110 in patients suffering from Tourette syndrome ("TS").
The work towards an IND submission is intended to open a U.S. clinical site that will take part in the phase IIb trial.
“We are very excited about expanding our clinical sites to the U.S., especially after positive results obtained in a clinical trial led by professor Bloch M.D., M.S., an associate professor in the Child Trial Center at Yale University, using our proprietary drug candidate," stated Dr. Adi Zuloff-Shani, SciSparc’ s CTO. "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. We believe our approach has significant advantages over available treatments and it is our intention to do everything in our ability to accelerate our trial in order to reach patients who are in need for effective treatment".
Previously, a Phase IIa trial conducted at the same site at Yale University showed that trial patients, which were TS medication-refractory, had a reduction of tic symptoms of 21% across the entire sample. Improvement over time with treatment was also observed when generalized linear models were used to analyze repeated measures data on the Yale Global Tic Severity Scale. In addition, no evidence of adverse events of clinical concern were observed.
Based on these positive results, the company is currently advancing into a phase IIb trial. The objective of this phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between 18 and 65 years of age).
The patients will be randomized in a 1:1 ratio to receive either SCI-110 or SCI-110 matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the most commonly used measure in clinical trials, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the trial will be to assess absolute and relative frequencies of serious adverse events for the entire population and separately for the SCI-110 and placebo groups.
The company has received the Ethics Committee approval from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel, which will be the two first sites of the phase IIb trial.
TS is a movement and neurobehavioral disorder characterized by chronic motor and vocal tics. With onset before age 18, about half to two-thirds of TS cases improve during adolescence, while adults are generally more severe patients. Tics may be associated with a premonitory sensation to perform a specific action, which may lead to “relief” once performed.
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