Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company
focused on Alzheimer’s disease, today announced the completion of a
third interim safety review of simufilam in on-going Phase 3
clinical trials in patients with Alzheimer’s disease. A routine,
scheduled meeting of a Data and Safety Monitoring Board (DSMB)
resulted in a recommendation that both of Cassava Sciences’
on-going Phase 3 studies continue as planned, without modification.
“We are pleased to have satisfactorily completed
this safety review, the last before the expected top-line read out
for our first Phase 3 study.” said Jim Kupiec, Chief Medical
Officer. “We look forward to announcing top-line efficacy, safety
and biomarker data for our 12-month Phase 3 study before the end of
2024.”
The DSMB is composed of independent clinical
research experts who periodically review interim patient safety
data for Cassava Sciences’ on-going Phase 3 trials of simufilam in
Alzheimer’s disease. This DSMB only reviews patient safety. It does
not assess drug efficacy.
On-going Phase 3 Studies with
Simufilam
Cassava Sciences’ simufilam is a novel, small
molecule drug candidate for the proposed treatment of Alzheimer’s
disease dementia. The drug is in late-stage clinical evaluation in
a pair of pivotal Phase 3 trials. These Phase 3 trials are fully
enrolled. Over 1,900 patients with mild-to-moderate Alzheimer’s
disease who also met other study eligibility criteria were
randomized into the trials.
The first Phase 3 trial (NCT04994483) has a
52-week treatment period; 804 Alzheimer’s patients were randomized
into this trial. Top-line results for the 52-week Phase 3 trial are
currently expected by year-end 2024.
The second Phase 3 trial (NCT05026177) has a
76-week treatment period; 1,125 Alzheimer’s patients were
randomized into this trial. Top-line results for the 76-week Phase
3 trial are currently expected approximately mid-year 2025.
Patients with mild-to-moderate Alzheimer’s
disease dementia who met study eligibility criteria were recruited
into the Phase 3 program from clinical sites in the U.S., Puerto
Rico, Canada, Australia and South Korea. Cassava Sciences is
conducting its on-going Phase 3 program in collaboration with
Premier Research International, a global contract research
organization (CRO).
Today’s news follows interim safety MRI data
announced in October 2023, which suggests simufilam is not
associated with treatment-emergent amyloid-related imaging
abnormalities (ARIA). In addition, September 2023 and March 2024
meetings of the DSMB recommended that both Phase 3 trials continue
as planned, without modification. Final safety data are expected at
the conclusion of the Phase 3 program.
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.
Simufilam is Cassava Sciences’ small molecule
oral drug candidate currently in Phase 3 clinical trials for the
treatment of Alzheimer's disease. Simufilam targets a specific site
on filamin A, a scaffolding protein that is critical to certain
receptor interactions in the brain. Cassava Sciences believes
that simufilam interrupts amyloid-β42 binding to receptors in the
brain and may affect the Alzheimer's disease process. Cassava
Sciences owns exclusive, worldwide rights to its investigational
product candidates 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 Officer(512)
501-2450ESchoen@CassavaSciences.com
Cautionary Note Regarding
Forward-Looking Statements and Other Notices: 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. These statements may be
identified by words such as “anticipate,” “believe,” “could,”
“expect,” “forecast,” “intend,” “may,” “plan,” “possible,”
“potential,” “will,” and other words and terms of similar
meaning.
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,
complete or announce top-line results of our clinical studies,
including efficacy, safety and biomarker data, on expected
timelines; the ability to demonstrate the specificity, safety,
efficacy or potential health benefits of our product candidates in
people with Alzheimer’s disease dementia; the interim safety status
or profile of simufilam to date in our Phase 3 clinical studies;
our current expectations regarding timing of clinical data for our
Phase 3 studies; any expected clinical results of Phase 3 studies;
the treatment of people with Alzheimer’s disease dementia; verbal
comments made by our employees regarding simufilam, safety, drug
effects, and the treatment of Alzheimer’s disease with simufilam;
potential benefits, if any, 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, 2023 and
Quarterly Report on Form 10-Q for the period ended June 30, 2024,
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.
All our pharmaceutical assets under development
are all investigational product candidates. These have not been
approved for use in any medical indication by any regulatory
authority in any jurisdiction and their safety, efficacy or other
desirable attributes, if any, have not been established in any
patient population. Consequently, none of our product candidates
are approved or available for sale anywhere in the world, and you
should not assume that they may ever be approved or available for
sale at any time.
Our clinical results from earlier-stage clinical
trials may not be indicative of future 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.
We are in the business of new drug discovery and
development. Our research and development activities are long,
complex, costly and involve a high degree of risk. Holders of our
common stock should carefully read our current Annual Report on
Form 10-K and Quarterly Reports on Form 10-Q in their entirety,
including the risk factors therein. Because risk is fundamental to
the process of drug discovery and development, you are cautioned to
not invest in our publicly traded securities unless you are
prepared to sustain a total loss of the money you have
invested.
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