Cassava Sciences Announces Completion of Dosing in Open-label Study of Simufilam for Alzheimer’s Disease
December 06 2022 - 8:15AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company, today announced the completion of drug
administration in an open-label study of simufilam for Alzheimer’s
disease. This study was designed to evaluate long-term drug safety
and to measure cognitive changes (ADAS-cog) over 12 months in
approximately 200 patients with mild-to-moderate Alzheimer’s
disease treated with open-label simufilam 100 mg twice daily.
Simufilam is Cassava Sciences’ oral drug candidate for Alzheimer’s
disease dementia.
To ensure the highest integrity of data
analysis, outside biostatisticians with specific expertise in
Alzheimer’s disease will conduct an independent statistical
analysis on the clinical dataset. Cassava Sciences may announce
study results approximately year-end 2022, pending completion of a
study report by outside biostatisticians.
“We are thrilled with the progress made to date
in the clinical development of simufilam, our oral drug candidate
for people with Alzheimer’s disease,” said Remi Barbier, President
& CEO. “We applaud recent clinical advances with anti-amyloid
antibody drugs for Alzheimer’s, but these may not be enough. I
think innovations are needed around new targets, new molecules,
drug safety and dosing. I believe Cassava Sciences may be at the
forefront of this effort to innovate.”
Overview of On-going Phase 3 Clinical
Program Cassava Sciences is evaluating simufilam for
Alzheimer’s disease dementia in two Phase 3 clinical studies. Both
studies have received a Special Protocol Assessment (SPA) from the
U.S. Food and Drug Administration. Over 750 patients are now
enrolled in the Phase 3 program.
Cassava Sciences’ RETHINK-ALZ Phase 3 study is
designed to evaluate the safety and efficacy of oral simufilam 100
mg in enhancing cognition and slowing functional decline over 52
weeks. This randomized, double-blind, placebo-controlled study
plans to enroll approximately 750 patients with mild-to-moderate
Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100
mg or matching placebo twice daily.
Cassava Sciences’ REFOCUS-ALZ Phase 3 study is
designed to evaluate the safety and efficacy of oral simufilam 100
mg and 50 mg over 76 weeks. This randomized, double-blind,
placebo-controlled study plans to enroll approximately 1,000
patients with mild-to-moderate Alzheimer’s disease. Patients are
randomized (1:1:1) to simufilam 100 mg, 50 mg, or placebo twice
daily.
Both Phase 3 studies have the same co-primary
efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a
functional scale).
About SimufilamSimufilam
(sim-uh-FILL-am) is Cassava Sciences’ proprietary, small molecule
(oral) drug that restores the normal shape and function of altered
filamin A (FLNA) protein in the brain. 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 Cassava Sciences,
Inc.Cassava Sciences is a clinical-stage biotechnology
company based in Austin, Texas. Our mission is to detect and treat
neurodegenerative diseases, such as Alzheimer’s disease. Our novel
science is based on stabilizing—but not removing—a critical protein
in the brain. Our product candidates have not been approved by any
regulatory authority, and their safety, efficacy or other desirable
attributes have not been established.
For more information, please visit:
https://www.CassavaSciences.com
For More Information Contact:
Eric Schoen, Chief Financial Officer(512) 501-2450, or
eschoen@CassavaSciences.com
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;
expectations regarding clinical results of our open-label study of
simufilam in Alzheimer’s disease; the size or composition of
patient enrollment in this open-label study; plans to release
clinical results of our open-label study, and the timing thereof;
the treatment of Alzheimer’s disease; the timing, enrollment,
duration, geography and other details of a Phase 3 clinical program
with simufilam; and potential benefits, if any, of simufilam. 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
interim data and analysis should not be relied upon as predictive
of full study results for any of our studies. 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, 2021, 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.
Cassava Sciences (NASDAQ:SAVA)
Historical Stock Chart
From Apr 2024 to May 2024
Cassava Sciences (NASDAQ:SAVA)
Historical Stock Chart
From May 2023 to May 2024