Pharma Focus Europe

Scisparc Granted Approval for Phase IIb Clinical Trial of Novel Treatment SCI-110 for Tourette Syndrome in Germany

Monday, July 03, 2023

SciSparc Ltd. (Nasdaq: SPRC), a clinical-stage pharmaceutical company specializing in therapies for central nervous system disorders, has received approval from the Federal Institute for Drugs and Medical Devices in Germany (BfArM) to conduct a Phase IIb clinical trial for its drug candidate, SCI-110. The trial will focus on treating adults with Tourette Syndrome (TS) and will take place at three renowned medical centers: the Yale Child Study Center at the Yale School of Medicine in the USA, the Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. Institutional Review Board (IRB) approvals have already been obtained from all three clinical sites, as well as approval from the Israeli Ministry of Health for the trial at Sourasky.

Oz Adler, the CEO of SciSparc, expressed enthusiasm about the approval, stating that it is a significant milestone for the company's efforts to develop innovative therapies for TS. SCI-110 is a promising candidate in their pipeline, and the Phase IIb trial will provide valuable data on its safety and efficacy, further establishing its potential as a game-changing therapy.

The BfArM's approval is conditional upon the submission of additional information regarding the release and stability of SCI-110 within 90 days.

The objective of the Phase IIb clinical trial is to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged between 18 and 65. The treatment will involve daily oral administration, and patients will be randomly assigned in a 1:1 ratio to receive either SCI-110 or a placebo. The primary efficacy objective will be to assess changes in tic severity using the Yale Global Tic Severity Scale, a commonly used measure in this type of clinical trial, at week 12 and week 26 compared to baseline. The primary safety objective will be to evaluate the occurrence and frequency of serious adverse events in the entire patient population and separately in the SCI-110 and placebo groups.

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