Cassava Sciences Announces Positive Interim Safety Review of Simufilam On-going Phase 3 Trials in Patients with Alzheimer’s Disease
18 Septiembre 2023 - 8:15AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology
company focused on Alzheimer’s disease, today announced a positive
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) recommended
that both of Cassava Sciences’ Phase 3 studies of simufilam
continue as planned, without modification.
“I think this first interim safety review is an
important milestone for the clinical development of simufilam,”
said Remi Barbier. “I find it very encouraging. We look forward to
announcing the completion of patient enrollment for both Phase 3
studies this year.”
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. The next routine meeting of the DSMB is
scheduled for March 2024.
On-going Phase 3 Studies with
SimufilamCassava Sciences is evaluating simufilam oral
tablets for Alzheimer’s disease dementia in two global Phase 3
clinical studies. These are randomized, double-blind,
placebo-controlled trials. The Phase 3 program aims to enroll a
total of approximately 1,750 patients with mild-to-moderate
Alzheimer’s disease who also meet other study eligibility criteria.
Patient enrollment is expected to be completed for both Phase 3
studies by yearend 2023. Both Phase 3 studies have received a
Special Protocol Assessment (SPA) from the U.S. Food and Drug
Administration.
About SimufilamSimufilam is
Cassava Sciences’ proprietary, small molecule (oral) drug candidate
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
product candidates have not been approved by any regulatory
authority, and their safety, efficacy or other desirable attributes
have not been established in humans.
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: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: the role, findings and
recommendations of the DSMB; the design, scope, conduct or intended
purpose of our Phase 3 program of simufilam in patients with
Alzheimer's disease; any findings by the DSMB for the interim
safety of simufilam in our on-going Phase 3 clinical trials; our
current expectations regarding timing of and the target patient
enrollment numbers for our Phase 3 studies; any expected clinical
results of Phase 3 studies; the treatment of patients with
Alzheimer’s disease dementia; comments made by our employees
regarding simufilam, drug effect, 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.
Simufilam is our investigational product
candidate. It is not approved by any regulatory authority in any
jurisdiction and its safety, efficacy or other desirable attributes
have not been established in patients.
Drug development involves a high degree of risk,
and only a small number of research and development programs result
in regulatory approval and commercialization of a product. Clinical
results from our prior studies may not be indicative of results of
future 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, any unanticipated impacts of inflation 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, 2022, 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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