SciSparc seeks FDA IND clearance for Phase IIb Tourette Syndrome treatment trial [Yahoo! Finance]
SciSparc Ltd. (SPRC)
Company Research
Source: Yahoo! Finance
its Phase IIb clinical trial of its drug candidate SCI-110 to treat Tourette Syndrome (TS). On receipt of approval, the trial is set to take place at three centres: the Yale Child Study Center at Yale School of Medicine, the Hannover Medical School, and the Tel Aviv Sourasky Medical Center. Institutional Review Board approvals have been obtained from all sites, alongside necessary approvals from the Israeli Ministry of Health and the Federal Institute for Drugs and Medical Devices in Germany. This trial aims to assess the safety, efficacy, and tolerability of daily oral doses of SCI-110 in adults aged between 18 and 65 years. Participants will be randomly assigned into a 1:1 ratio to receive either SCI-110 or a matched placebo. The primary efficacy endpoint will be the change in tic severity at weeks 12 and 26 compared to baseline. The safety of SCI-110 will also be assessed, with a focus on the frequency of serious adverse events in the overall population and in the groups
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News
- SciSparc receives FDA approval for trial for Tourette syndrome therapy [Yahoo! Finance]Yahoo! Finance
- SciSparc Secures FDA Green Light to US Launch of its Pivotal Phase IIb Clinical Trial for Breakthrough Tourette Syndrome Treatment [Yahoo! Finance]Yahoo! Finance
- SciSparc Secures FDA Green Light to US Launch of its Pivotal Phase IIb Clinical Trial for Breakthrough Tourette Syndrome TreatmentGlobeNewswire
- SciSparc Signs Non-Binding Letter of Intent to Sell Stake in MitoCareX [Yahoo! Finance]Yahoo! Finance
- SciSparc Signs Non-Binding Letter of Intent to Sell Stake in MitoCareXGlobeNewswire
SPRC
Sec Filings
- 11/4/24 - Form 6-K
- 10/23/24 - Form 6-K
- 10/22/24 - Form 6-K
- SPRC's page on the SEC website