SciSparc Aims to Change Tourette Syndrome Treatments; Will Start a Phase IIb Trial with its Innovative Pharma-Grade THC-Based Medication
10 Novembre 2023 - 3:10PM
SciSparc Ltd. (Nasdaq: SPRC), a specialty clinical-stage
pharmaceutical company focusing on the development of therapies to
treat disorders and rare diseases of the central nervous system,
announced the initiation of its Phase IIb clinical trial treating
patients suffering from Tourette Syndrome (TS) with its SCI-110,
proprietary drug candidate.
The trial is being conducted under the regulation of the U.S.
Food and Drug Administration (FDA), the Federal Institute for Drugs
and Medical Devices in Germany (BfArM) and the Israeli Ministry of
Health. SciSparc initiated the trial at the Tel Aviv Sourasky
Medical Center in Israel (Sourasky) and is expected to proceed with
its U.S. and Germany-based medical sites. The Company has already
secured institutional review board approval from all three clinical
sites, approval from the Israeli Ministry of Health for the
clinical trial at Sourasky, and approval from BfArM for conducting
the trial at the Hannover Medical School.
TS is a movement and neurobehavioral disorder characterized by
motor and vocal tics and is highly linked with co-morbidities. As
the currently used medications are managing only a small number of
disease symptoms with limited efficacy and questionable safety,
there is a clear unmet medical need for the management of TS.
SCI-110 contains Dronabinol (FDA approved synthetic form of
THC), with the endocannabinoid palmitoylethanolamide (PEA).
Designed to stimulate cannabinoid receptors across the central
nervous system and inhibit the metabolic degradation of
endocannabinoids in order to improve uptake of THC, the expected
benefits of SCI-110 are more efficient through oral administration,
and in turn a decrease in dosage requirements, side effects and
adverse events.
The objective of this clinical trial is to evaluate the
efficacy, safety and tolerability of SciSparc's proprietary drug
candidate SCI-110 in adult patients (between 18 and 65 years of
age) using a daily oral treatment. The patients will be randomized
at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched
placebo. The primary efficacy objective of the trial will be to
assess tic severity change using the Yale Global Tic Severity
Scale, the most commonly used measure in clinical trials of this
kind, as a continuous endpoint at week 12 and week 26 of the
double-blind phase compared to baseline. The primary safety
objective of the trial is to assess absolute and relative
frequencies of serious adverse events for the entire population
and, separately, for the SCI-110 and placebo groups.
Results from the Company's Phase IIA clinical trial conducted at
Yale University demonstrated an average tic reduction of 21% across
the entire sample with almost 40% of the patients experiencing
greater than 25% in tic reduction as defined by YGTSS-TTS (a
clinician-rated instrument considered as the gold standard for
assessing tics in patients with TS). In addition, the medication
was generally well-tolerated by subjects and 12 out of the 16
subjects elected to continue into a 24-week extension phase of the
trial.
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 trial’s objective to evaluate
efficacy, safety and tolerability of SCI-110; and the trial
is expected to proceed with its U.S. and Germany-based medical
sites. 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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