SciSparc Submits IND Application for Tourette Syndrome Drug

SciSparc Advances Tourette Syndrome Treatment

SciSparc Ltd. (Nasdaq: SPRC), a dedicated clinical-stage pharmaceutical company, is excited to announce a significant step forward in its commitment to addressing Tourette Syndrome (TS). The company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration, marking the launch of a Phase IIb clinical trial for its proprietary drug candidate, SCI-110.

Planned Trial Locations

This promising study will take place at three well-respected centers of excellence: one at the Yale Child Study Center in the U.S., another at Hannover Medical School in Germany, and the third at the Tel Aviv Sourasky Medical Center in Israel. The collaboration among these globally recognized institutions is set to enhance the credibility and comprehensiveness of the trial, which has already received the necessary approvals from relevant ethics boards and health authorities.

Trial Objectives and Methodology

The main goal of this Phase IIb trial is to thoroughly assess 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 matched placebo, with a 1:1 ratio. Efficacy will be monitored by measuring changes in tic severity using the widely recognized Yale Global Tic Severity Scale, as participants are evaluated at weeks 12 and 26 of the double-blind phase.

Evaluating Safety and Efficacy

Key focus will also be placed on safety, where the frequency and nature of serious adverse events will be closely monitored across both treatment groups. This structured approach ensures that researchers can collect valuable data regarding both the benefits and potential risks associated with SCI-110.

About SciSparc Ltd.

SciSparc Ltd. is not just focused on Tourette Syndrome; its vision encompasses a broader range of therapies aimed at rare central nervous system disorders. The company is engaged in the development of several promising drug programs. These include SCI-110 for Tourette Syndrome, aimed at not only improving the lives of those affected by TS but also exploring applications for Alzheimer’s disease and agitation.

Innovative Drug Development Programs

Additionally, SciSparc is working on SCI-210, which is intended for treating Autism Spectrum Disorder (ASD) and status epilepticus. The commitment to cannabinoid pharmaceutical technologies positions SciSparc as a leader in innovative treatments.

Connecting with Investors

The future looks promising for SciSparc as it continues to build an impressive portfolio of technologies. The company also has a controlling interest in a subsidiary focused on marketing hemp seed oil-based products through platforms like Amazon Marketplace. This diverse approach not only strengthens the company's market presence but also aligns with its objectives of enhancing available therapies for various medical conditions.

Frequently Asked Questions

What is the purpose of SciSparc's Phase IIb trial?

The Phase IIb trial aims to evaluate the efficacy, safety, and tolerability of the SCI-110 drug candidate in adults with Tourette Syndrome.

Where will the clinical trial take place?

The trial will be conducted at three prestigious centers: the Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center.

What are the primary measures for the trial?

The primary measures include changes in tic severity assessed by the Yale Global Tic Severity Scale and monitoring of adverse events.

What other conditions is SciSparc developing treatments for?

Besides Tourette Syndrome, SciSparc is also focused on developing therapies for Alzheimer’s disease, agitation, Autism Spectrum Disorder, and status epilepticus.

How can individuals contact the company for more information?

For inquiries, individuals can reach SciSparc at IR@scisparc.com or by calling +972 3-761-7108.

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