SciSparc Celebrates Major Breakthrough: Positive Results Show its Treatment has a Remarkable Impact on Alzheimer's Agitation
15 Noviembre 2023 - 7:01AM
SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage
pharmaceutical company focusing on the development of therapies to
treat disorders of the central nervous system (the “Company” or
“SciSparc”), unveiled positive topline results from its
investigator-initiated Phase IIa trial at the Sophie & Abraham
Stuchynski Israeli Alzheimer’s Medical Center (IMCA). The trial
results indicated that SciSparc’s proprietary SCI-110 provided a
safe and effective solution for alleviating agitation in elderly
Alzheimer's patients who participated.
Agitation is a devastating symptom of Alzheimer's Disease (AD),
afflicting nearly all patients as the disease progresses, and
imposing tremendous suffering and caregiving burdens. Existing
treatments, including off-label medications, have questionable
efficacy and come with notable side effects.
SciSparc’s open-label Phase IIa trial, conducted at IMCA,
encompassed 18 AD patients grappling with agitation. It aimed to
assess the safety, tolerability, and effectiveness of SCI-110,
administered orally twice daily. The results not only met primary
endpoints regarding tolerability and adverse events but also
demonstrated SCI-110's potential to alleviate agitation without
side effects.
Importantly, patients treated with SCI-110 were free of
delirium, oversedation, hypotension, or falls, demonstrating its
potential safety and suitability for elderly patients. Moreover,
when measured by the Cohen Mansfield Agitation Inventory (CMAI),
our treatment led to a significant 23% reduction in agitation
symptoms. These results were further corroborated by the Edinburgh
Feeding Evaluation in Dementia Scale, which showed a decline in
eating and feeding difficulties.
“We are thrilled with these outcomes, as they signify a
monumental potential in enhancing the lives of AD patients. Our
commitment to pioneering innovative treatments with a global impact
has never been clearer," said Dr. Adi Zuloff- Shani, Chief
Technologies Officer of SciSparc.
The trial, titled "Phase IIa Open Label Trial to Evaluate the
Safety, Tolerability and Efficacy Trend of SCI-110 in Patients with
Alzheimer's Disease and Agitation," was conducted at IMCA under the
guidance of Dr. Alexander Kaplan, MD, a board-certified
geriatrician and principal investigator. This single-arm,
open-label trial saw each subject receiving SCI-110 twice daily via
oral administration, with follow-up for up to 39 days.
SCI-110 is a unique combination of FDA-Approved Dronabinol and
the Company’s proprietary CannAmide™ formulation, creating a
powerful solution for AD patients. SciSparc’s cannabinoid-centric
approach enhances efficacy which allows lowering cannabinoid dose
leading to a decrease in side effects compared to standalone
cannabinoids.
AD is an urgent global health concern, and existing treatments
fall short of meeting the needs of patients. SciSparc is committed
to changing this reality and providing hope to millions
worldwide.
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. The
Company also owns a controlling interest in a subsidiary whose
business focusses on the sale of hemp-based products on
the Amazon.com marketplace.
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 safety, efficacy,
advantages and benefits of SCI-110 in the elderly population with
AD and agitation; and SciSparc’s efforts to develop proprietary
innovative treatments with the ability to change millions of lives
worldwide. 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 May 1, 2023, 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.comTel:
+972-3-6167055
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