Cassava Sciences Initiates a Second Phase 3 Study of Simufilam for the Treatment of Patients with Alzheimer’s Disease
18 Novembro 2021 - 11:15AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company,
announced today it has initiated a second Phase 3 study of
simufilam, the Company’s investigational drug for patients with
Alzheimer’s disease. This second Phase 3 study is designed to
evaluate the safety and efficacy of simufilam over 78 weeks in
approximately 1,000 patients with Alzheimer’s disease across
clinical sites in the U.S. and Canada.
“Alzheimer’s disease isn’t going away anytime
soon, and neither are we,” said Remi Barbier, President & CEO.
“Developing a new drug solution for Alzheimer’s is a daunting task
during the best of times. During these times of outlandish
allegations made against us by short sellers, we stand committed to
translate what we believe is a promising scientific breakthrough
into a potentially meaningful treatment for people with Alzheimer’s
disease. The rest is noise.”
Cassava Sciences’ Phase 3 program in Alzheimer’s
is being conducted under Special Protocol Assessments (SPA) from
the U.S. Food and Drug Administration (FDA). The SPAs document that
FDA has reviewed and agreed on the key design features of each
Phase 3 study protocol.
Cassava Sciences is developing simufilam in
accordance with high ethical standards and sound scientific
principles. Cassava Sciences is committed to transparency and
sharing information related to its Phase 3 program – for clinical
protocol details, including patient eligibility, please visit:
https://clinicaltrials.gov/ct2/results?cond=&term=simufilam&cntry=&state=&city=&dist=
About The First Phase 3 Study
(RETHINK-ALZ)The first Phase 3 study, called RETHINK-ALZ,
is designed to evaluate the safety and efficacy of oral simufilam
100 mg in enhancing cognition and slowing cognitive and functional
decline over 52 weeks. Secondary objectives include the assessment
of simufilam's effect on neuropsychiatric symptoms and caregiver
burden. This randomized, double-blind, placebo-controlled study
plans to enroll approximately 750 patients with mild-to-moderate
Alzheimer’s disease in the U.S. and Canada and, eventually,
overseas. We commenced patient screening for RETHINK-ALZ in October
2021, followed by patient dosing in November 2021.
About The Second Phase 3 Study
(REFOCUS-ALZ)The second Phase 3 study, called REFOCUS-ALZ,
is designed to evaluate the safety and efficacy of oral simufilam
100 mg and 50 mg over 78 weeks. This randomized, double-blind,
placebo-controlled study plans to enroll approximately 1,000
patients with mild-to-moderate Alzheimer’s disease in the U.S. and
Canada and, eventually, overseas.
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)
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 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’ 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 press release
includes forward looking statements including but not limited to
those regarding the size and scope of our Phase 3 program with
simufilam in Alzheimer’s disease, the expected treatment benefits
of simufilam for people with Alzheimer’s disease and oral or
written comments made by our employees regarding simufilam and its
clinical development.
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 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 initiation, conduct or completion of our
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, as
supplemented by the section entitled “Risk Factors” in our
Quarterly Report on SEC Form 10-Q for the quarter ended September
30, 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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