Cassava Sciences Announces Initiation of an Open-label Extension Study
October 13 2022 - 9:15AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced the initiation of an open-label extension study. This
study is designed to provide no-cost access to simufilam, an
investigational drug, to patients with Alzheimer’s disease who
complete either one of Cassava Sciences’ on-going Phase 3 studies,
which are double-blind, placebo-controlled trials.
“We believe this open-label study is the right
thing to do,” said Remi Barbier, President & CEO. “Alzheimer’s
patients who complete one of our Phase 3 studies are eligible to
enroll, knowing there is no placebo and no blinding in our
open-label extension study.”
Open-label Extension Study
DesignThis multi-center, multi-national, open-label
extension study is expected to generate long-term safety and
tolerability data for (oral) simufilam 100 mg twice daily over 52
weeks. Each clinical investigational site must choose whether to
participate in this open-label extension study. Patient enrollment
for this study is expected to begin early November 2022.
For more information about the
open-label-extension study, please visit ClinicalTrials.gov:
https://www.clinicaltrials.gov/ct2/show/NCT05575076?term=simufilam&draw=2&rank=1
Overview of On-going Phase 3 Clinical
Program Our Phase 3 program consists of two double-blind,
randomized, placebo-controlled studies of simufilam, with an
enrollment target of approximately 1,750 patients with
mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have
Special Protocol Assessments (SPA) from the U.S. Food and Drug
Administration. For more information about our Phase 3 studies,
please visit ClinicalTrials.gov:
https://www.clinicaltrials.gov/ct2/show/NCT04994483?term=simufilam&draw=2&rank=3https://www.clinicaltrials.gov/ct2/show/NCT05026177?term=simufilam&draw=2&rank=4
About SimufilamSimufilam, an
investigational drug, 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, Inc. 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. For more information,
please visit: https://www.CassavaSciences.com.
For More Information Contact:
Eric Schoen, Chief Financial Officer
(512) 501-2450
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 current expectations regarding
the open-label extension study; comments made by our employees
regarding simufilam and the treatment of Alzheimer’s disease; 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, 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.
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