SciSparc Ltd. renewed clinical trial approval for SCI-210, targeting autism treatment with proprietary CBD formulation.
Quiver AI Summary
SciSparc Ltd. has renewed its approval from the Israeli Medical Cannabis Agency to conduct a clinical trial for its drug SCI-210, a combination of cannabidiol (CBD) and CannAmide™, aimed at treating children with autism spectrum disorder (ASD). This trial, taking place at Soroka University Medical Center, will involve 60 participants aged 5 to 18 and will compare SCI-210 to standard CBD treatment over a 20-week period, measuring efficacy and safety through various assessments. The approval is set for 30 days, pending further confirmation from the Israeli police department. With previous ethical and health ministry approvals secured, SciSparc is poised to advance research for ASD treatments, looking to initially commercialize SCI-210 in Israel before expanding internationally.
Potential Positives
- Renewal of clinical trial approval for SCI-210 from the Israeli Medical Cannabis Agency underscores regulatory compliance and supports the progression of the trial in children with autism spectrum disorder.
- Successful completion of previous approvals from the Soroka University Medical Center Ethics Committee and the Israeli Ministry of Health indicates strong organizational capability in navigating regulatory frameworks for clinical studies.
- The clinical trial is poised to generate valuable data on the efficacy and safety of SCI-210, potentially advancing treatment options for individuals with ASD and addressing unmet medical needs.
- Plans for commercialization of SCI-210 in the Israeli market, followed by potential international expansion, highlight the company's growth prospects and commitment to developing innovative solutions in the pharmaceutical space.
Potential Negatives
- The renewal of approval for the clinical trial is for only 30 days, indicating potential regulatory scrutiny or delays in securing longer-term permissions.
- Final approval for the continuation of the trial is pending from the Israeli police department, which adds another layer of uncertainty regarding the trial's progress.
- The reliance on forward-looking statements highlights the inherent risks and uncertainties in the company's projections for the efficacy and safety of SCI-210, which could lead to investor concern.
FAQ
What is SciSparc's SCI-210 clinical trial about?
SciSparc's SCI-210 clinical trial focuses on evaluating the efficacy and safety of a CBD and CannAmide™ combination in children with autism spectrum disorder.
How long will the clinical trial for SCI-210 last?
The clinical trial for SCI-210 involves a 20-week treatment program for participants aged 5 to 18 with ASD.
Where is the SCI-210 clinical trial being conducted?
The trial is being conducted at Soroka University Medical Center in Israel.
What approvals has SciSparc received for the trial?
SciSparc has received approvals from the Israeli Medical Cannabis Agency, Soroka University Medical Center Ethics Committee, and the Israeli Ministry of Health.
What is the expected outcome of the SCI-210 trial?
The trial aims to generate valuable data to advance treatment options for individuals with autism spectrum disorder (ASD).
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SPRC Hedge Fund Activity
We have seen 4 institutional investors add shares of $SPRC stock to their portfolio, and 3 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- UBS GROUP AG added 65,653 shares (+1958.0%) to their portfolio in Q3 2024
- RENAISSANCE TECHNOLOGIES LLC removed 39,700 shares (-100.0%) from their portfolio in Q3 2024
- TWO SIGMA SECURITIES, LLC added 37,082 shares (+inf%) to their portfolio in Q3 2024
- CITADEL ADVISORS LLC removed 23,862 shares (-100.0%) from their portfolio in Q3 2024
- VIRTU FINANCIAL LLC added 14,106 shares (+inf%) to their portfolio in Q3 2024
- TWO SIGMA INVESTMENTS, LP removed 12,177 shares (-100.0%) from their portfolio in Q3 2024
- MORGAN STANLEY added 233 shares (+4660.0%) to their portfolio in Q3 2024
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Full Release
TEL AVIV, Israel, Dec. 31, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced the renewal of its approval from the Israeli Medical Cannabis Agency ("IMCA") at the Israeli Ministry of Health to conduct its clinical trial for SCI-210 in children with autism spectrum disorder ("ASD"). SCI-210 is a proprietary combination of cannabidiol (“CBD”) and CannAmide™.
This renewal reaffirms the Company's compliance with IMCA regulatory requirements and enables the continued progression of its clinical trial. The approval was received for a period of 30 days and will be extended pending the final approval by the Israeli police department, which is expected to be received within 30 days. SciSparc has also previously received the necessary approvals from the Soroka University Medical Center Ethics Committee and the Israeli Ministry of Health to conduct the trial, advancing its innovative treatments for ASD.
The clinical trial for SCI-210 is a double-blind, randomized, and placebo-controlled study conducted at Soroka University Medical Center in Israel, involving 60 children aged 5 to 18 with ASD. The trial aims to evaluate the efficacy and safety of SCI-210, a proprietary combination of CBD and CannAmide™ (SciSparc's novel Palmitoylethanolamide formulation), compared to standard CBD monotherapy. Participants will undergo a 20-week treatment program, focusing on symptom management and therapeutic outcomes.
The study’s primary efficacy metrics include the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) scale, and the determination of an effective therapeutic dose. The Company believes that this trial, designed in consultation with Israel's National Autism Research Center, is expected to generate valuable data to advance treatment options for individuals with ASD.
With commercialization of SCI-210 planned first in the Israeli market and subsequent expansion internationally, subject to regulatory approvals, SciSparc is dedicated to offering innovative solutions that address the unmet needs of individuals with ASD and their families.
About SciSparc Ltd. (Nasdaq: SPRC):
SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of autism and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds’ oil-based products on the
Amazon.com
Marketplace.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses the the potential efficacy and safety of SCI-210, its expectation that the results of the clinical trial will generate valuable data to advance treatment options for individuals with ASD and the commercialization of SCI-210 in the Israeli and international market. Because such statements deal with future events and are based on SciSparc’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on April 1, 2024, and in subsequent filings with the SEC. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
Investor Contact:
IR@scisparc.com
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