EXCLUSIVE: SciSparc's Tourette Syndrome Candidate Receives IRB Approval To Start Phase 2b Study In US

SciSparc Ltd SPRC has received Institutional Review Board (IRB) approval for its Phase 2b clinical trial for SCI-110 in subjects suffering from Tourette Syndrome.

Tourette Syndrome is a nervous system condition in which people have "tics." 

Tics are sudden twitches, movements, or sounds that people repeatedly do. People who have tics cannot stop their bodies from doing these things.

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What Happened: The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale (YGTSS-R-TTS), the most commonly used measure in clinical trials, as a continuous endpoint at week 12 and week 26 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 says the previously conducted Phase 2a trial showed that SCI-110 was safe and effective, where acute TS medication-refractory subjects treated with SCI-110 significantly reduced tic symptoms by 21% across the entire sample. 

An improvement over time with treatment was also observed. 

Price Action: SPRC shares are up 3.70% at $0.55 during the premarket session on the last check Wednesday.