Cassava Sciences Announces Initiation of Cognition Maintenance Study in Alzheimer’s disease
May 10 2021 - 08:30AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced the initiation of a Cognition Maintenance Study (CMS) to
evaluate simufilam in patients with Alzheimer’s disease. Simufilam
is a drug candidate that seeks to reduce neurodegeneration and
neuroinflammation. Cassava Sciences believes the ability to impact
more than one aspect of Alzheimer’s disease represents a new and
crucial approach to treatment.
“We’ve observed good safety and cognitive
improvements in study participants treated with open-label
simufilam,” said Remi Barbier, President & CEO. “The CMS is a
randomized, controlled study designed to evaluate changes in
cognition over six months in study participants who continue with
drug treatment versus those who stop treatment. We believe clinical
data from the CMS may inform the benefit-risk assessments that
drive regulatory decisions.”
In addition to initiating the CMS and conducting
an on-going open-label study, Cassava Sciences’ strategic focus for
2021 is to advance simufilam in a Phase 3 program in Alzheimer’s
disease, to complete clinical readiness activities in support of
the Phase 3 program, and to continue to lead the Company to deliver
the full potential of its product portfolio.
About the Cognition Maintenance Study
(CMS)The CMS is a double-blind, multi-center, randomized,
placebo-controlled clinical study in subjects with mild-to-moderate
Alzheimer’s disease. Upon enrolling into the CMS, all study
participants will already have completed at least one year of
open-label treatment with simufilam. CMS participants will be
randomized (1:1) to simufilam 100 mg tablets twice-daily or
matching placebo for six months. The CMS design includes measures
of safety and a single primary endpoint of cognition, measured on
ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive subscale).
Target enrollment is up to 100 subjects across multiple study sites
in the U.S. and Canada.
About SimufilamSimufilam 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. Cassava Sciences is also
developing an investigational diagnostic, called SavaDx, to detect
Alzheimer’s disease with a simple blood test. Simufilam and SavaDx
were both developed in-house. Both product candidates are
substantially funded by peer-review research grant awards from the
National Institutes of Health (NIH). 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.
About Alzheimer’s
Disease Alzheimer’s disease is a progressive brain
disorder that destroys memory and thinking skills. Currently, there
are no drug therapies to halt Alzheimer’s disease, much less
reverse its course. 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. For more information, please
visit: https://www.CassavaSciences.com
For More Information Contact:
Eric Schoen, Chief Financial OfficerESchoen@CassavaSciences.com
(512) 501-2450
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: our strategy and plans; the
treatment of Alzheimer’s disease; the status of current and future
clinical studies with simufilam, including the interpretation of an
interim analysis of an open-label study; planned enrollment
targets; our intention to initiate a Phase 3 clinical program with
simufilam and the timing, enrollment, duration and other details
thereof; 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 and commercialization involve a high
degree of risk, and only a small number of research and development
programs result in commercialization of a product. Our clinical
results from 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 and accessed May 7, 2021.
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