SciSparc Delivers Treatment for Autism Spectrum Disorder Clinical Trial Enabling Commencement of Dosing
SciSparc Ltd. (Nasdaq: SPRC) has successfully completed manufacturing and delivering its SCI-210 treatment for a clinical trial on pediatric patients with Autism Spectrum Disorder (ASD). The trial will evaluate the safety, tolerability, and efficacy of SCI-210 compared to CBD monotherapy, with primary endpoints including the Aberrant Behavior Checklist-Community (ABC-C) and Clinical Global Impressions-Improvement (CGI-I) scale.
The initiation of a clinical trial for the SCI-210 treatment in pediatric patients with Autism Spectrum Disorder (ASD) represents a significant step forward for SciSparc Ltd. and its stakeholders. The proprietary combination of cannabidiol-rich oil and CannAmide™ has the potential to offer a novel therapeutic option for ASD, a condition for which treatment options are currently limited.
From a research perspective, the design of the trial as a randomized, double-blind, placebo-controlled study with cross-over is robust, aiming to minimize bias and provide reliable data on the treatment's efficacy and safety. The use of established efficacy endpoints, such as the ABC-C and CGI-I, is crucial as they are recognized measures within the field of behavioral disorders and will facilitate the comparison of SCI-210's efficacy against current standards.
The pharmaceutical industry often faces challenges in determining optimal dosing, especially in pediatric populations. Therefore, the determination of effective therapeutic dosage is of particular importance, as it can lead to a better safety profile and potentially improve patient adherence to medication regimes.
For investors, SciSparc Ltd.'s announcement is noteworthy due to the implications it has for the company's future revenue streams and market positioning. Successful clinical trials can lead to regulatory approval and commercialization, which in turn can significantly impact a company's financial health. The focus on a pediatric indication, a demographic often underserved in terms of tailored medication, could open up a new market segment for SciSparc.
Furthermore, the biopharmaceutical sector is highly competitive and investors will be closely monitoring the trial's progress for any competitive advantages that SCI-210 may offer over existing ASD treatments. The potential for a safer and more effective treatment could position SciSparc favorably in the market, but it is essential to consider the risks inherent in clinical development, including trial delays or failure to demonstrate efficacy.
Long-term value creation will depend on the trial outcomes and subsequent steps towards commercialization, including potential partnerships, marketing strategies and scalability of production. The mention of commercialization intentions in Israel indicates initial market focus, which could be a strategic move to establish the product in a smaller market before global expansion.
The development of treatments for ASD is a complex field due to the heterogeneous nature of the disorder. The combination therapy of CBD and CannAmide™ by SciSparc could represent a significant advancement in the management of ASD symptoms. The safety profile is particularly critical in pediatric populations, where long-term effects of treatments are a major concern for both healthcare providers and parents.
It is also worth noting that CBD has been gaining attention in various neurological disorders, but its use in pediatrics remains controversial due to limited data on long-term effects. The inclusion of CannAmide™, a compound designed to enhance the effects of CBD, could potentially offer a more targeted approach with fewer side effects. This trial will provide valuable data not only on the efficacy but also on the safety and tolerability of such a combination in children.
Given the global prevalence of ASD and the lack of effective treatments, successful trial results could have a significant impact on the standard of care. The trial's findings will be critical in shaping future research and treatment protocols for ASD.
02/29/2024 - 08:35 AM
The SCI- 210 treatment is now available at clinical site for autism spectrum disorder clinical trial in pediatric patients, in accordance with enrollment initiat ion
TEL AVIV, Israel, Feb. 29, 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 completed the manufacturing of and delivered its innovative SCI- 210 treatment, in accordance with its initiation of enrollment for the clinical trial at the Soroka Medical Center of pediatric patients who have Autism Spectrum Disorder ("ASD").
The Company's proprietary SCI- 210 treatment combines cannabidiol-rich oil (“CBD”) and CannAmide™, SciSparc’s proprietary palmitoylethanolamide-based tablets.
"A clinical trial is a complicated project composed of many little steps- which in turn help ensure successful execution. Having the clinical supply ready on site is the final step before first patient is administered treatment. We are extremely excited to achieve this milestone and are confident in the potential of our treatment to improve patients’ lives by providing them with a more effective and safe treatment. Our unique technology allows us to use lower doses of the active agent, which leads to increased safety without harming its effectiveness" said SciSparc’s Chief Executive Officer, Oz Adler. "We hope that the outcome of this clinical trial will enable the Company to procced with its commercialization of SCI- 210 in Israel."
The clinical trial will rigorously examine 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 clinical trial will span 20 weeks and enroll 60 children. The clinical 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 Company’s belief in the potential of its treatment to improve patients’ lives, that the outcome of the clinical trial will enable the Company to proceed with commercialization of SCI- 210 in Israel, and the design of the upcoming clinical trial. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. 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
What is the purpose of the SCI-210 treatment in the clinical trial for pediatric patients with Autism Spectrum Disorder (ASD)?
The purpose is to evaluate the safety, tolerability, and efficacy of SCI-210 compared to CBD monotherapy.
What are the primary efficacy endpoints of the clinical trial involving SCI-210?
The primary endpoints include the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) scale, and determining the effective therapeutic dosage.
How many children will be enrolled in the clinical trial for SCI-210?
The trial will enroll 60 children.
What unique technology does SciSparc use in the SCI-210 treatment?
SciSparc uses a combination of cannabidiol-rich oil (CBD) and CannAmide™ tablets in the SCI-210 treatment.
Who is the Chief Executive Officer of SciSparc?
Oz Adler is the Chief Executive Officer of SciSparc.
