Business
SciSparc Announces Expanding its Clinical Operations to Include a U.S. Site Towards its Phase IIb Trial with its Proprietary SCI-110 for the Treatment of Tourette Syndrome
TEL AVIV, Israel, July 08, 2022 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company
About this update from Scisparc Ltd.
[{"type":"text","content":"TEL AVIV, Israel, July 08, 2022 (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 started the process of preparing for an Investigational New Drug Application (“IND”) with the U.S. Food and Drug Administration (“FDA”) 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 Prof. Bloch M.D., M.S., an associate Professor in the Child Trial Center at Yale University, using our proprietary drug candidate,\" commented Dr. Adi Zuloff-Shani, SciSparc’ s Chief Technologies Officer. \"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 (“YGTSS-TTS”). 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 cha...