SciSparc Announces Ethics Committee Approval to Conduct its Clinical Trial in Autism Spectrum Disorder
23 June 2022 - 11:30PM
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 it has received approval from the Ethics
Committee of The Soroka University Medical Center, in Be'er-Sheva,
Israel (the “Ethics Committee”), to conduct the Company’s clinical
trial for SCI-210 in patients suffering from Autism Spectrum
Disorder ("ASD").
The trial will investigate the effect of the
Company’s drug candidate SCI-210, a proprietary combination of
cannabidiol (“CBD”) and CannAmide™, versus CBD monotherapy, in
treating ASD.
The trial's objectives are to evaluate the safety,
tolerability and efficacy of SCI-210 in children with ASD in a
designed 20-week, randomized, double-blind, placebo controlled with
a cross-over clinical trial of 60 children. The trial has three
primary efficacy end points: 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.
“We are honored to receive the Ethics Committee
approval, an important step toward initiation of our clinical trial
in ASD,” commented Oz Adler, SciSparc's Chief Executive Officer. We
believe that our unique and proprietary SCI-210 has the potential
to be a new treatment to reduce irritability and other symptoms
associated with ASD in pediatric patients, a condition with limited
available treatments. Just a month ago we announced the Ethics
Committee approval of our novel and proprietary SCI-110 for the
treatment of Tourette Syndrome and today with great enthusiasm we
announce the Ethic Committee’s approval of our novel and
proprietary SCI-210 platform. These approvals are important
milestones for SciSparc and they demonstrate our commitment to
change the life of millions. Our drug candidates potentially
enable us to provide effective and safer treatments with fewer side
effects thanks to the lower doses of active ingredients, boosted by
the combination with CannAmide™, a mission always desirable but
even more so when children are the target population."
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.
The launch of the trial is pending further
approvals by the Israeli Ministry of Health and the Israeli Medical
Cannabis Agency.
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 (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 autism spectrum disorder and status
epilepticus.
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 initiation of the
Company’s clinical trial in ASD and further regulatory approvals in
Israel to conduct its ASD research trial with The Soroka University
Medical Center. Historic 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 U.S.
Securities and Exchange Commission (the “SEC”) on April 28, 2022,
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
Tel: +972-3-6167055
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