SciSparc Successfully Completed The Development of its Proprietary Drug Candidate SCI-110 for its Upcoming Phase IIb Study In Tourette Syndrome
June 29 2022 - 8:30AM
SciSparc Ltd. (Nasdaq: SPRC) (the "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 successfully completed the
development of its top-tier drug candidate SCI-110 to be used in
its upcoming multinational, multicenter, Phase IIb study for
Tourette Syndrome ("TS").
The Company recently announced that it has
received ethics committee approvals from Hannover Medical School in
Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel
Aviv, Israel. SCI-110 is developed and manufactured by Procaps
Group S.A., a leader in contract development and manufacturing
services in soft-gel advanced technologies for the global
pharmaceutical industry.
"Completing the development of our unique drug
candidate SCI-110 for the upcoming Phase IIb trial is another
significant milestone for the Company, making SciSparc well
positioned to introduce an impactful treatment for TS patients that
have very limited treatment options today," commented Oz Adler,
SciSparc's Chief Executive Officer. "Our singular objective in
developing SCI-110 is to develop a safe and effective treatment for
this devastating, unmet medical need as soon as possible; and this
milestone brings us one step closer.”
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) using oral
treatment daily. The patients will be randomized in a 1:1 ratio to
receive either SCI-110 or a 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 Germany and
Israel.
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 forthcoming phase
IIb clinical trial for treatment of TS and the pending further
regulatory approvals in Germany and Israel. 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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