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SciSparc Receives Approval to Conduct Phase IIb Clinical Trial for SCI-110 to Treat Tourette Syndrome in Germany
The Federal Institute for Drugs and Medical Devices in Germany granted the Company approval to use SCI-110 in a clinical trial at the Hannover Medical School
About this update from Scisparc Ltd.
[{"type":"text","content":" The Federal Institute for Drugs and Medical Devices in Germany granted the Company approval to use SCI-110 in a clinical trial at the Hannover Medical School TEL AVIV, Israel, June 30, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (\"Company\" or \"SciSparc\"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced it has been granted an approval from the Federal Institute for Drugs and Medical Devices in Germany (“BfArM”) for its Phase IIb clinical trial to use SCI-110 for treating adults with Tourette Syndrome (\"TS\") at the Hannover Medical School in Hannover, Germany. The Phase IIb clinical trial will be conducted at three global leading centers of excellence: the Yale Child Study Center at the Yale School of Medicine in Connecticut, USA, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center (“Sourasky”) in Tel Aviv, Israel. The Company has already secured the Institutional Review Board (“IRB) approvals from all three clinical sites as well as the Israeli Ministry of Health's approval for the clinical trial at Sourasky. \"We are excited to announce that SciSparc has received another official approval to embark on its Phase IIb Clinical Trial for SCI-110, aimed at treating TS, in Germany. This significant milestone marks another pivotal moment in our path to develop and approve innovative therapeutic solutions for patients suffering from this complex neurological disorder,\" stated SciSparc’s Chief Executive Officer, Oz Adler. \"SCI-110 represents a promising candidate in our pipeline, leveraging cutting-edge research and breakthrough scientific advancements. This Phase IIb Clinical Trial will enable us to rigorously evaluate the safety and efficacy of SCI-110, and we believe will further solidify its potential as a game-changing therapy.\" Authorization from the BfArM has been granted on the condition that some additional information for the release and stability of SCI-110 will be provided within 90 days. The objective of this clinical 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) using a daily oral treatment. The patients will be randomized in a 1:1 ratio to rece...