SciSparc Submits IND for SCI-110 Trial in Tourette Syndrome
SciSparc Submits IND Application for SCI-110 Phase IIb Clinical Trial
SciSparc Ltd. (Nasdaq: SPRC), a specialty clinical-stage pharmaceutical company, has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Phase IIb clinical trial featuring SCI-110, a promising treatment for Tourette Syndrome (TS).
Innovative Treatment Approach
The company’s proprietary SCI-110 integrates dronabinol and palmitoylethanolamide, providing a unique therapeutic opportunity for individuals suffering from TS. SciSparc’s Chief Executive Officer, Oz Adler, emphasized that their approach could transform current treatment paradigms for TS, addressing limitations of existing therapies.
Clinical Trial Overview
The Phase IIb trial is set to take place at three advanced medical centers: the Yale Child Study Center at the Yale School of Medicine, Hannover Medical School in Germany, and Tel Aviv Sourasky Medical Center. The company has already secured the necessary Institutional Review Board approvals and other essential clearances for the trial.
Objectives of the Trial
This clinical trial aims to assess the efficacy, safety, and tolerability of SCI-110 among adult patients aged 18 to 65. The patients will be randomized to receive either SCI-110 or a matching placebo in a 1:1 ratio. The primary focus will be on evaluating changes in tic severity using the Yale Global Tic Severity Scale, with assessments made at weeks 12 and 26.
Safety and Monitoring Measures
In addition to evaluating efficacy, the study will monitor the occurrence of serious adverse events to ensure comprehensive safety analysis across both treatment and placebo groups. This rigorous approach underscores SciSparc’s commitment to patient safety and the integrity of the trial results.
About SciSparc Ltd.
SciSparc Ltd. operates as a leading pharmaceutical entity focused on developing cannabinoid-based therapies. The company’s portfolio includes therapeutic programs targeting Tourette Syndrome, Alzheimer's disease, agitation, autism spectrum disorders, and status epilepticus. Particularly notable is their commitment to leveraging advancements in cannabinoid pharmaceuticals to create innovative treatment solutions.
Outlook and Future Directions
The submission of the IND application marks a pivotal milestone for SciSparc as it advances toward clinical trials. The ongoing development of SCI-110 reflects the company’s mission to revolutionize therapeutic approaches for neurological and psychiatric disorders.
Investor Relations
For inquiries about investment and company operations, you may contact SciSparc directly via email or phone: Email: IR@scisparc.com, Phone: +972-3-6167055.
Frequently Asked Questions
What is the purpose of the IND application submitted by SciSparc?
The IND application is for the Phase IIb clinical trial of SCI-110 aimed at treating Tourette Syndrome.
Where will the clinical trials take place?
The trials are set to occur at the Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center.
What does SCI-110 contain?
SCI-110 consists of dronabinol and palmitoylethanolamide, aimed at treating Tourette Syndrome.
What is the age range for participants in the clinical trial?
The trial will involve adult participants aged 18 to 65 years.
How will the efficacy of SCI-110 be measured?
Efficacy will be assessed using the Yale Global Tic Severity Scale at designated intervals throughout the trial.
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