Cassava Sciences, Inc. (Nasdaq: SAVA) today announced positive
clinical data with SavaDx, an investigational diagnostic/biomarker
to detect Alzheimer’s disease with a simple blood test. SavaDx was
used to measure plasma levels of altered filamin A before and after
simufilam treatment in patients with Alzheimer’s disease. In this
Phase 2b randomized, controlled trial sponsored by the National
Institutes of Health (NIH), simufilam significantly reduced plasma
levels of altered filamin A in Alzheimer’s patients treated for 28
days. Plasma levels of p-tau181 also dropped significantly in these
same patients.
Simufilam 100 mg and 50 mg reduced plasma levels
of altered filamin A by 48% (p=0.003) and 44% (p=0.02)
respectively, versus placebo. Additionally, simufilam 100 mg and 50
mg reduced plasma levels of p-tau181 by 17% (p=0.01) and 15%
(p=0.02) respectively, versus placebo. Plasma p-tau181 is a
biomarker that is known to be elevated in Alzheimer’s disease.
“We believe altered filamin A is a major culprit
in Alzheimer’s disease,” said Remi Barbier, President & CEO.
“Before simufilam treatment, SavaDx detected high plasma levels of
altered filamin A in patients. After simufilam treatment, levels
dropped significantly. We believe these data provide clear evidence
that simufilam binds to and engages its intended target to produce
treatment effects.”
Treatment effects on CSF biomarkers for this
Phase 2b study have been previously reported.
About Today’s Poster
Presentation at AAICScientists for Cassava Sciences will
show a poster presentation titled, “SavaDx, a Novel Plasma
Biomarker to Detect Alzheimer’s Disease, Confirms Mechanism of
Action of Simufilam” at the Alzheimer’s Association International
Conference (AAIC) in Denver, CO and virtually. Cassava Sciences’
AAIC poster presentation with SavaDx can be accessed on the
‘Investors’ page of the Company’s website:
https://www.CassavaSciences.com
About SavaDxSavaDx is Cassava
Sciences’ investigational diagnostic to detect Alzheimer’s disease.
The goal of SavaDx is to make the detection of Alzheimer’s as
simple as getting a blood test, possibly years before the
appearance of any overt clinical symptoms. SavaDx was substantially
funded by a peer-reviewed research grant award from the National
Institutes of Health (NIH).
About SimufilamSimufilam
(sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that
restores the normal shape and function of altered filamin A (FLNA),
a scaffolding protein, in the brain. Altered FLNA in the brain
disrupts the normal function of neurons, leading to Alzheimer’s
pathology, neurodegeneration and neuroinflammation. The underlying
science for simufilam is published in peer-reviewed journals,
including Journal of Neuroscience, Neurobiology of Aging, Journal
of Biological Chemistry, Neuroimmunology and Neuroinflammation
and Journal of Prevention of Alzheimer’s Disease. Simufilam is
substantially supported by peer-reviewed research grant awards from
the National Institutes of Health (NIH).
About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys
memory and thinking skills. As of 2020, there were approximately 50
million people worldwide living with dementia, a figure expected to
increase to 150 million by 2050.1 The annual global cost of
dementia is now above $1 trillion, according to Alzheimer’s Disease
International, a charitable organization.
About Cassava Sciences,
Inc.Cassava Sciences’ mission is to discover and develop
innovations for chronic, neurodegenerative conditions. Over the
past 10 years, Cassava Sciences has combined state-of-the-art
technology with new insights in neurobiology to develop novel
solutions for Alzheimer’s disease.
Simufilam and SavaDx were both developed
in-house. Cassava Sciences owns worldwide development and
commercial rights to its research programs in Alzheimer’s disease,
and related technologies, without royalty obligations to any third
party.
For more information, please visit
https://www.CassavaSciences.com
For More Information Contact:
Eric Schoen, Chief Financial
Officereschoen@CassavaSciences.com(512) 501-2450
Cassava Sciences’ open-label study of simufilam
in Alzheimer’s disease is funded by clinical research grant
#AG065152 from the National Institutes of Health (NIH/NIA).
The content of this press release is solely the
responsibility of Cassava Sciences and does not necessarily
represent the official views of the NIH/NIA.
Cautionary Note Regarding
Forward-Looking Statements: This news release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, relating to: the treatment of Alzheimer’s
disease; the interpretation of data with SavaDx from a randomized
controlled Phase 2b study of simufilam; the interpretation of
biomarker data from a Phase 2b study of simufilam; verbal
commentaries made by our employees; and potential benefits, if any,
of our product candidates. These statements may be identified by
words such as “may,” “anticipate,” “believe,” “could,” “expect,”
“would”, “forecast,” “intend,” “plan,” “possible,” “potential,” and
other words and terms of similar meaning.
Drug development involves a high degree of risk,
and historically only a small number of research and development
programs result in commercialization of a product. Clinical results
from our earlier-stage clinical trials may not be indicative of
full results or results from later-stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements or any scientific data we
present or publish.
Such statements are based largely on our current
expectations and projections about future events. Such statements
speak only as of the date of this news release and are subject to a
number of risks, uncertainties and assumptions, including, but not
limited to, those risks relating to the ability to conduct or
complete clinical studies on expected timelines, to demonstrate the
specificity, safety, efficacy or potential health benefits of our
product candidates, the severity and duration of health care
precautions given the COVID-19 pandemic, any unanticipated impacts
of the pandemic on our business operations, and including those
described in the section entitled “Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2020 and future
reports to be filed with the SEC. The foregoing sets forth many,
but not all, of the factors that could cause actual results to
differ from expectations in any forward-looking statement. In light
of these risks, uncertainties and assumptions, the forward-looking
statements and events discussed in this news release are inherently
uncertain and may not occur, and actual results could differ
materially and adversely from those anticipated or implied in the
forward-looking statements. Accordingly, you should not rely upon
forward-looking statements as predictions of future events. Except
as required by law, we disclaim any intention or responsibility for
updating or revising any forward-looking statements contained in
this news release.
For further information regarding these and
other risks related to our business, investors should consult our
filings with the SEC, which are available on the SEC's website at
www.sec.gov.
1 Alzheimer's Disease International, Dementia Statistics,
available on-line.
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