SciSparc Announces Expanding its Clinical Operations to Include a U.S. Site Towards its Phase IIb Trial with its Proprietary SCI-110 for the Treatment of Tourette Syndrome
July 08 2022 - 8:30AM
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 it has started the process of preparing for an
Investigational New Drug Application (“IND”) with the U.S. Food and
Drug Administration (“FDA”) for its Phase IIb clinical trial for
SCI-110 in patients suffering from Tourette Syndrome ("TS").
The work towards an IND submission is intended to open a U.S.
clinical site that will take part in the phase IIb trial.
“We are very excited about expanding our clinical sites to the
U.S., especially after positive results obtained in a clinical
trial led by Prof. Bloch M.D., M.S., an associate Professor in the
Child Trial Center at Yale University, using our proprietary drug
candidate," commented Dr. Adi Zuloff-Shani, SciSparc’ s Chief
Technologies Officer. "Expanding this trial, is part of our overall
efforts to expedite the development of SCI-110 for TS, which is a
greatly underserved therapeutic area. We believe our approach has
significant advantages over available treatments and it is our
intention to do everything in our ability to accelerate our trial
in order to reach patients who are in need for effective
treatment".
Previously, a Phase IIa trial conducted at the same site at Yale
University showed that trial patients, which were TS
medication-refractory, had a reduction of tic symptoms of 21%
across the entire sample. Improvement over time with treatment was
also observed when generalized linear models were used to analyze
repeated measures data on the Yale Global Tic Severity Scale
(“YGTSS-TTS”). In addition, no evidence of adverse events of
clinical concern were observed. Based on these positive results,
the Company is currently advancing into a phase IIb trial. The
objective of this phase IIb randomized, multi-national,
multi-center, double-blind, placebo controlled cross-over 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). The patients will be randomized in a 1:1
ratio to receive either SCI-110 or SCI-110 matched placebo. The
primary efficacy objective of the trial will be to assess tic
severity change using the most commonly used measure in clinical
trials, 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 will be to assess absolute and relative
frequencies of serious adverse events for the entire population and
separately for the SCI-110 and placebo groups.
The Company recently announced it has received the Ethics
Committee approval from Hannover Medical School in Hannover,
Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv,
Israel, which will be the two first sites of the phase IIb
trial.
TS is a movement and neurobehavioral disorder characterized by
chronic motor and vocal tics. With onset before age 18, about half
to two-thirds of TS cases improve during adolescence, while adults
are generally more severe patients. Tics may be associated with a
premonitory sensation to perform a specific action, which may lead
to “relief” once performed.
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 potential benefits of SCI-110
treatment and its plans for the phase IIb randomized,
multi-national, multi-center, double-blind, placebo controlled
cross-over trial, and SciSparc’s plans to explore additional
clinical sites to join the clinical trial. 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 SEC on April 28, 2022, 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.comTel:
+972-3-6167055
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