SciSparc Announces Ethics Committee Approval to Conduct a Phase IIb Trial in Tourette Syndrome
May 26 2022 - 08:30AM
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 received Ethics Committee approvals from
Hannover Medical School in Hannover, Germany, and the Tel Aviv
Sourasky Medical Center, in Tel Aviv, Israel, to conduct the
Company’s Phase IIb clinical study for SCI-110 in patients
suffering from Tourette Syndrome ("TS"). The Company is evaluating
additional clinical sites to join the Phase 2b trial to expedite
patient enrollment in a timely manner.
“We are delighted and honored to receive Ethics Committee
approval, an important step toward initiation of our Phase IIb
trial in TS,” commented Oz Adler, SciSparc's Chief Executive
Officer. "We are encouraged by the Phase IIa study conducted at
Yale University, which demonstrated that SCI-110 was able to
significantly decrease symptoms over time in adult subjects with
TS, and we are excited about achieving another significant
milestone to further the Company's clinical program. TS is one of
our leading indications and we believe that we could make a real
change in patients' lives and their quality of life while reducing
side effects, thanks to our unique technology."
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.
The objective of this Phase IIb randomized, multi-national,
multi-center, double-blind, placebo controlled cross-over study 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 study will be to assess tic
severity change using Yale Global Tic Severity Scale (YGTSS-R-TTS),
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 study 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 launch of the trial is pending approvals by
the Ministry of Health in both countries.
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 study, 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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