SciSparc Submits IND Application for SCI-110 Phase IIb Clinical Trial
SciSparc Ltd. (Nasdaq: SPRC), a clinical-stage pharmaceutical company specializing in innovative treatments, has announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Phase IIb clinical trial of SCI-110, a promising therapy for Tourette Syndrome (TS).
Innovative Treatment Approach
The proprietary SCI-110 combines dronabinol and palmitoylethanolamide, offering a unique therapeutic option for those affected by TS. Oz Adler, the Chief Executive Officer of SciSparc, highlighted that this approach has the potential to change current treatment methods for TS, overcoming the limitations of existing therapies.
Clinical Trial Overview
The Phase IIb trial will be conducted at three leading medical institutions: the Yale Child Study Center at the Yale School of Medicine, Hannover Medical School in Germany, and Tel Aviv Sourasky Medical Center. SciSparc has already obtained the necessary Institutional Review Board approvals and other critical clearances to proceed with the trial.
Objectives of the Trial
This clinical trial aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18 to 65. Participants will be randomly assigned to receive either SCI-110 or a matching placebo in a 1:1 ratio. The primary goal is to assess changes in tic severity using the Yale Global Tic Severity Scale, with evaluations scheduled at weeks 12 and 26.
Safety and Monitoring Measures
Alongside efficacy evaluations, the study will also monitor the occurrence of serious adverse events to ensure a thorough safety analysis for both treatment and placebo groups. This comprehensive approach reflects SciSparc’s dedication to patient safety and the reliability of the trial outcomes.
About SciSparc Ltd.
SciSparc Ltd. is a prominent pharmaceutical company focused on developing cannabinoid-based therapies. Its portfolio includes various therapeutic programs targeting conditions such as Tourette Syndrome, Alzheimer's disease, agitation, autism spectrum disorders, and status epilepticus. The company is particularly committed to utilizing advancements in cannabinoid pharmaceuticals to create innovative treatment options.
Outlook and Future Directions
The submission of the IND application represents a significant milestone for SciSparc as it progresses towards clinical trials. The ongoing development of SCI-110 aligns with the company’s mission to transform therapeutic strategies for neurological and psychiatric disorders.
Investor Relations
If you have questions regarding investments or company operations, you can reach out to 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 intended for the Phase IIb clinical trial of SCI-110, which aims to treat Tourette Syndrome.
Where will the clinical trials take place?
The clinical trials are scheduled to occur at the Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center.
What does SCI-110 contain?
SCI-110 is composed of dronabinol and palmitoylethanolamide, specifically designed for the treatment of Tourette Syndrome.
What is the age range for participants in the clinical trial?
The trial will include adult participants aged between 18 and 65 years.
How will the efficacy of SCI-110 be measured?
The efficacy will be evaluated using the Yale Global Tic Severity Scale at specified intervals throughout the trial.
