SciSparc Announces Initiation of Patient Recruitment for its Clinical Trial with SCI-210 in Children with Autism Spectrum Disorder
- SCI-210 clinical trial initiated in Israel for children with autism spectrum disorder
- SCI-210 is a combination of cannabidiol (CBD) and CannAmide™ designed to alleviate ASD symptoms
- The goal is to commercialize SCI-210 first in Israel and then in other countries
- The trial has three primary efficacy metrics: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician, and the effective therapeutic dose
- The trial was designed in consultation with the National Autism Research Center in Israel
- None.
Insights
The initiation of patient recruitment for SciSparc's SCI-210 clinical trial represents a significant step in the development of new treatments for autism spectrum disorder (ASD). The study's design—a double-blind, randomized and placebo-controlled trial—adheres to the gold standard for clinical research, ensuring that the results will have scientific credibility. The inclusion of 60 subjects over a 20-week period provides a substantial data set for assessing the effectiveness of SCI-210 compared to standard CBD treatment.
From a medical research perspective, the combination of cannabidiol (CBD) with CannAmide™ could offer a novel therapeutic approach, potentially improving the symptom management of ASD. The proprietary nature of SCI-210 may give SciSparc a competitive edge in the market, especially if the trial outcomes demonstrate a significant improvement over existing treatments. The focus on the three primary efficacy metrics—the ABC-C questionnaire, the CGI-I assessment and the effective therapeutic dose—will provide a comprehensive understanding of SCI-210's impact on ASD symptoms.
SciSparc's strategic decision to conduct the SCI-210 trial in Israel before targeting international markets is a calculated move. Israel's regulatory environment and the company's existing presence there could expedite the commercialization process, assuming the trial results are favorable. The success of SCI-210 in Israel could serve as a proof of concept, bolstering investor confidence and potentially facilitating regulatory approval in other countries.
ASD represents a significant and growing market, with increasing awareness and diagnosis rates. The development of effective treatments is a pressing need and if SCI-210 proves successful, it could capture a substantial share of this market. However, investors should be aware of the risks inherent in clinical trials, including the possibility of negative outcomes or insufficient differentiation from existing treatments, which could impact the company's valuation and stock performance.
The financial implications of the clinical trial for SciSparc's SCI-210 are multifaceted. Positive trial results could lead to increased market valuation due to the potential revenue streams from a new ASD treatment. Moreover, the proprietary nature of SCI-210 might allow for patent protection, contributing to long-term revenue generation. Investors should monitor the trial's progress and results closely, as they will directly impact the company's financial health and future investment opportunities.
It is essential to consider the cost of the clinical trial and the subsequent commercialization phase. These expenses can be substantial and the company's ability to manage them effectively will be critical for its financial stability. Investors should also be cognizant of the competitive landscape, as any competitors developing similar treatments could affect SciSparc's market positioning and profitability.
The clinical trial for SCI-210 will be conducted in Israel, after which the company aims to move forward with the commercialization process of SCI-210 first in the Israeli market
TEL AVIV, Israel, Jan. 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 of the central nervous system, today announces the initiation of patient recruitment for its clinical trial in children suffering from autism spectrum disorder ("ASD") at Soroka Medical Center in Israel.
The double-blind, randomized and placebo-controlled study will be performed using SciSparc's proprietary SCI-210, a combination of cannabidiol (CBD) and CannAmide™(SciSparc’s Palmitoylethanolamide), which is designed to alleviate ASD symptoms. SciSparc will enroll 60 subjects between the ages of five and 18, for 20 weeks, with the purpose of assessing how SCI-210 therapy compares to standard CBD treatment in managing symptoms of ASD.
The Company's goal is to sell SCI-210 first in Israel and then in other countries, subject to obtaining the requisite regulatory approvals.
"The initiation of patient recruitment for this clinical study, that has the potential to address an area of unmet medical need, marks an exciting milestone for the team at SciSparc as it aligns with our mission to improve human health through the development of novel therapies," said SciSparc’s Chief Executive Officer, Oz Adler. “We hope the outcome of the trial will enable the Company to procced with the commercialization process for SCI-210 in Israel."
The trial has three primary efficacy metrics: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician; and the effective therapeutic dose. The trial was designed in consultation with the National Autism Research Center, the leading research center for autism in Israel.
ASD is a condition related to brain development that impacts how a person perceives and socializes with others, causing problems in social interaction and communication. The term "spectrum" in autism spectrum disorder refers to the wide range of symptoms and severity.
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 Amazon 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 prospective design and objectives of the clinical trial, the Company’s commercialization intent with regards to SCI-210, the potential of the clinical study to address ASD, and the potential commercialization of SCI-210 in Israel. 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
Tel: +972-3-6167055
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