SciSparc
Announces Ethics Committee Approval to Conduct a Phase IIb Trial in
Tourette Syndrome
Ethics
Committee approval received from the two sites that will conduct
the SCI-110 trial in Germany and Israel
TEL AVIV, Israel, May 26,
2022 -- InvestorsHub NewsWire -- 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.com
Tel:
+972-3-6167055