SciSparc Signs Clinical Trial Agreement with Yale University to Conduct its Phase IIb Trial in Tourette Syndrome
August 01 2022 - 9:30AM
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 the addition of another site of excellence, the
Yale Child Study Center at Yale University, to its Phase IIb
clinical trial for SCI-110 in patients suffering from Tourette
Syndrome ("TS").
The trial will be led by Dr. Michael H. Bloch, M.D., M.S., an
associate Professor in the Child Study Center at Yale University
and a leading researcher in the field of TS.
Yale University is the third medical center to join SciSparc’s
multi-national, multi-center trial. Previously, SciSparc announced
the Hannover Medical School in Hannover, Germany, and the Tel Aviv
Sourasky Medical Center in Tel Aviv, Israel as medical center trial
sites of excellence.
“We are very excited about the opportunity to return and
collaborate with Dr. Bloch and his team at Yale University. We see
this as an expression of confidence in the potential of the drug we
are developing for the treatment of Tourette’s patients," commented
Dr. Adi Zuloff-Shani, SciSparc’ s Chief Technologies Officer.
"Importantly, this Phase IIb trial is a unified trial, as the
trial’s data are expected to qualify for regulatory submissions
with both the FDA (U.S. Federal Drug Administration) and the EMA
(European Medicines Agency). We look forward to further expanding
this trial, as part of the overall team effort working to develop a
treatment for this therapeutic area, which is greatly underserved,
and we believe our approach has significant advantages over
available treatments.”
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. Tic symptoms are prevalent in
TS cases and may be associated with a premonitory sensation to
perform a specific action, which may lead to “relief” once
performed.
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 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).
Patients will be randomized in a 1:1 ratio to
receive either SCI-110 or placebo.
The primary efficacy objective of the trial 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
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.
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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