SciSparc Announces Enrollment of First Patient for its Clinical Trial for Children with Autism Spectrum Disorder
March 08 2024 - 7:11AM
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 that the first patient has been enrolled in the
Company's clinical trial assessing the efficacy and safety of
SCI-210 for the treatment of children with autism spectrum disorder
(“ASD”) between the ages of 5 and 18.
Autism, also referred to as autism spectrum disorder, is one of
the most common developmental disabilities globally with a
prevalence of approximately one in 36 children, according to
estimates from the Centers for Disease Control and Prevention’s
Autism and Developmental Disabilities Monitoring (ADDM)
Network and is accompanied by an unmet need for efficient and safe
treatments.
“Scientific innovation cannot forge ahead without patients that
are willing to work with the scientific community by participating
in clinical trials. The enrollment of our first patient means that
we are moving towards a new frontier in the treatment of ASD,” said
Oz Adler, SciSparc’s Chief Executive Officer. “We are pleased to
enroll the first patient in the trial, which will further our
understanding of the potential role of SCI-210 in the treatment of
ASD symptoms."
The Company's goal is to sell SCI-210 first in Israel and then
in other countries, subject to obtaining the requisite regulatory
approvals.
About the ASD trial:
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 5
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 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 Company’s vision for treating ASD
through clinical trials testing the SCI-210 composition and its
goal to sell SCI-210 in Israel and other countries subject to the
requisite regulatory approvals. 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
SciSparc (NASDAQ:SPRC)
Historical Stock Chart
From Mar 2024 to Apr 2024
SciSparc (NASDAQ:SPRC)
Historical Stock Chart
From Apr 2023 to Apr 2024