SciSparc Achieves Major Milestone with First Patient Dosed in Autism Spectrum Disorder Clinical Trial
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Insights
The dosing of the first patient in SciSparc Ltd.'s SCI-210 clinical trial for Autism Spectrum Disorder (ASD) represents a pivotal step in the drug development process. This phase of clinical research is critical in determining the safety and efficacy of potential treatments for ASD, which is a complex neurodevelopmental disorder affecting communication and behavior. Given the limited number of effective treatments currently available for ASD, the progress of this trial could have significant implications for the company's valuation and future revenue streams if the treatment proves to be successful.
Investors and stakeholders should monitor the trial's progression closely, as positive interim results could lead to an increase in the company's stock price due to heightened investor optimism. Conversely, any setbacks or negative outcomes could adversely affect investor sentiment. It's also important to consider the potential market size for a new ASD treatment, which could be substantial given the prevalence of the disorder. The Centers for Disease Control and Prevention (CDC) estimates that approximately 1 in 54 children in the U.S. is diagnosed with ASD, indicating a significant patient population that could benefit from an effective therapy.
From a financial perspective, the initiation of a clinical trial can be a capital-intensive period for a biopharmaceutical company like SciSparc Ltd. Research and development costs are likely to increase, impacting the company's short-term financials. However, investors often view these expenses as necessary investments in the company's pipeline. The potential long-term financial benefits of a successful treatment for ASD could outweigh the current R&D expenditures, especially if the treatment gains market approval and captures a significant share of the ASD therapy market.
Investors should also consider the competitive landscape of ASD treatments and the patent life of the therapy in development when evaluating the company's future prospects. If SCI-210 demonstrates a clear advantage over existing treatments in terms of efficacy, safety, or ease of use, it could command premium pricing and enjoy strong market adoption. Moreover, partnerships or licensing agreements with larger pharmaceutical companies could provide additional revenue streams and reduce the financial risk for SciSparc.
The advancement of the SCI-210 clinical trial can also be viewed through an economic lens, particularly in terms of its potential impact on healthcare costs and productivity. ASD is associated with significant economic burden due to the cost of healthcare services, special education and caregiver time. An effective treatment could reduce these costs and improve the quality of life for individuals with ASD and their families.
Furthermore, the success of this trial could stimulate investment and job creation in the biotech sector, particularly in regions where the research and development activities are taking place. The economic ripple effects of a breakthrough in ASD treatment could extend beyond the immediate healthcare sector, potentially impacting various industries through increased demand for related healthcare products and services.
First patient has been dosed in the randomized, controlled, double blind clinical trial for Autism Spectrum Disorder in pediatric patients
TEL AVIV, Israel, March 14, 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 and rare diseases of the central nervous system, today announced that it has successfully dosed the first patient in its SCI-210 clinical trial at the Soroka Medical Center for pediatric patients who have Autism Spectrum Disorder ("ASD"). This significant milestone follows the Company's recent announcement about the successful delivery of its innovative SCI-210 treatment to the clinical trial site, enabling the commencement of dosing.
SciSparc's proprietary SCI-210 treatment combines cannabidiol-rich oil (“CBD”) and CannAmide™, SciSparc’s proprietary palmitoylethanolamide-based tablets. The dosing of the first patient signifies the transition from preparatory phases to active treatment evaluation in the quest to offer a more effective and safe treatment option for ASD.
"Dosing the first patient is always an exciting moment in any clinical trial. As we work to offer new hope to the patients, family members, and caretakers who are battling this disorder, we are excited to kick-off this next phase of development for SCI-210,” said Oz Adler, SciSparc's Chief Executive Officer. "We are thrilled to reach this milestone, which brings us one step closer to potentially offering a new beacon of hope for patients and families affected by ASD. We are grateful to the patients, Professor Meiri and his team involved in the clinical trial. This achievement represents a pivotal moment for SciSparc as we introduce SCI-210, an innovative cannabinoid-based treatment."
The clinical trial aims to rigorously evaluate the safety, tolerability, and efficacy of SCI-210 in comparison to CBD monotherapy for the treatment of ASD. Designed as a randomized, double-blind, placebo-controlled clinical trial with cross-over, the study will span 20 weeks and enroll 60 children. The trial's primary efficacy endpoints include three rigorous assessments: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) scale administered by healthcare professionals; and the determination of the effective therapeutic dosage.
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 CBD: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI- 210 for the treatment of ASD 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 aims of the SCI-210 clinical trial. 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 May 1, 2023, and in subsequent filings with the U.S. Securities and Exchange Commission. 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
Tel: +972-3-6167055
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