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SciSparc Receives FDA Approval to Initiate Phase IIb Clinical Trial for Tourette Syndrome Treatment
FDA confirms that SciSparc’s study may proceed following the application submission a month ago TEL AVIV, Israel, Sept. 23, 2024 (GLOBE NEWSWIRE) -- SciSparc
About this update from Scisparc Ltd.
[{"type":"text","content":"FDA confirms that SciSparc’s study may proceed following the application submission a month ago TEL AVIV, Israel, Sept. 23, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (\"Company\" or \"SciSparc\"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced that the U.S. Food and Drug Administration (“FDA”) has confirmed that its investigational new drug (“IND”) application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome (“TS”). SciSparc has taken a major step forward with its proprietary SCI-110 for the treatment of Tourette Syndrome (“TS”) with its submission of an IND application to the FDA for its phase IIb clinical trial, as previously announced on August 23, 2024. 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, United States, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center in Israel. The Company has already secured the Institutional Review Board approvals from all three clinical sites, as well as approval from all related federal administrations. Oz Adler, Chief Executive Officer of SciSparc, said “We are very excited to reach this milestone with our first-in-class platform SCI-110 which reinforces our ambition to become a leading company to provide safe and effective treatments to patients with central nervous system disorders. The application was swiftly approved by the FDA within a month after its submission, together with the excellent results we received using this platform in the previous Phase IIa clinical trial, reinforces our belief in our ability to offer a novel safe and effective treatment for Tourette’s patients.” 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 the ages of 18 and 65 years) using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change usi...