SciSparc submits IND for Tourette Syndrome trial
Ticker: SPRC · Form: 6-K · Filed: Aug 26, 2024 · CIK: 1611746
| Field | Detail |
|---|---|
| Company | Scisparc Ltd. (SPRC) |
| Form Type | 6-K |
| Filed Date | Aug 26, 2024 |
| Risk Level | medium |
| Pages | 1 |
| Reading Time | 1 min |
| Sentiment | neutral |
Sentiment: neutral
Topics: clinical-trial, FDA, drug-development
TL;DR
SciSparc just filed an IND with the FDA for a Tourette's Phase IIb trial using SCI-110.
AI Summary
On August 23, 2024, SciSparc Ltd. announced it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase IIb clinical trial. This trial will evaluate SCI-110 for patients diagnosed with Tourette Syndrome.
Why It Matters
This submission is a critical step towards initiating a new clinical trial for Tourette Syndrome, potentially advancing treatment options for affected patients.
Risk Assessment
Risk Level: medium — The company is seeking regulatory approval for a clinical trial, which carries inherent risks related to trial success, patient recruitment, and regulatory hurdles.
Key Players & Entities
- SciSparc Ltd. (company) — Filer of the report and developer of SCI-110
- SCI-110 (drug) — Investigational drug for Tourette Syndrome
- U.S. Food and Drug Administration (FDA) (company) — Regulatory body receiving the IND application
- Tourette Syndrome (condition) — Target condition for the clinical trial
- August 23, 2024 (date) — Date of the press release announcing the IND submission
FAQ
What is the purpose of the IND application submitted by SciSparc Ltd.?
The IND application was submitted to the FDA to seek approval for a Phase IIb clinical trial to evaluate SCI-110 for patients with Tourette Syndrome.
What is the specific drug being tested in the proposed clinical trial?
The drug being tested is SCI-110.
What medical condition is the clinical trial intended to address?
The clinical trial is intended to address Tourette Syndrome.
What is the phase of the clinical trial for which the IND was submitted?
The IND was submitted for a Phase IIb clinical trial.
When was the press release announcing the IND submission issued?
The press release was issued on August 23, 2024.
Filing Stats: 345 words · 1 min read · ~1 pages · Grade level 8.8 · Accepted 2024-08-26 06:15:26
Filing Documents
- ea021226902-6k_scisparc.htm (6-K) — 13KB
- ea021226902ex99-1_scisparc.htm (EX-99.1) — 9KB
- 0001213900-24-072345.txt ( ) — 23KB
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. SciSparc Ltd. Date: August 26, 2024 By: /s/ Oz Adler Name: Oz Adler Title: Chief Executive Officer and Chief Financial Officer 3