Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company,
today announced the completion of patient enrollment in a pivotal
Phase 3 clinical trial. Eight hundred four (804) Alzheimer’s
patients are enrolled in this 12-month trial. A second Phase 3
clinical trial with a target enrollment of approximately 1,100
patients is expected to complete patient enrollment in Q4 2023.
Both on-going Phase 3 clinical trials are evaluating the safety and
efficacy of oral simufilam in patients with Alzheimer's disease
dementia.
Simufilam is Cassava Sciences’ proprietary oral
drug candidate. This investigational drug binds to altered filamin
A protein in the brain and restores its normal shape and function.
By targeting altered filamin A, simufilam may help patients with
Alzheimer’s achieve better health outcomes.
Today’s news comes on the heels of a recently
announced positive interim safety review of simufilam in Cassava
Sciences’ on-going Phase 3 clinical trials in Alzheimer’s disease.
A recent meeting of a Data and Safety Monitoring Board (DSMB)
recommended that both Phase 3 studies of simufilam continue as
planned, without modification.
“We are pleased to announce the completion of
patient enrollment in our first pivotal Phase 3 trial of simufilam
in Alzheimer’s,” said James Kupiec, MD, Chief Medical Officer. “We
are grateful to the patients, investigators and our CRO who have
helped achieve this milestone.”
“Cassava Sciences is honored to be developing a
new drug treatment for people living with Alzheimer’s disease,”
said Remi Barbier President & CEO. “Alzheimer’s is a medical
condition with high unmet needs. It merits the development of drug
innovations that aim to go beyond removing amyloid from the brain.
We think simufilam is advancing towards that goal.”
On-going Phase 3 Clinical Program of
Simufilam
Cassava Sciences is evaluating oral simufilam
for Alzheimer’s disease dementia in two global, randomized,
double-blind, placebo-controlled Phase 3 clinical studies. Both
Phase 3 studies have received a Special Protocol Assessment (SPA)
from the U.S. Food and Drug Administration.
Our first Phase 3 trial has a 12-month treatment
period and has enrolled 804 patients with mild-to-moderate
Alzheimer’s disease who also meet other study eligibility criteria.
For more detailed information about our ongoing 12-month, Phase 3
trial, please visit www.ClinicalTrials.gov:
https://clinicaltrials.gov/study/NCT04994483?term=simufilam&rank=5
Our second Phase 3 trial has an 18-month
treatment period and continues to enroll patients with
mild-to-moderate Alzheimer’s disease who also meet other study
eligibility criteria. For more detailed information about our
on-going, 18-month, Phase 3 trial, please visit:
https://clinicaltrials.gov/study/NCT05026177?term=simufilam&rank=4
About Simufilam
Simufilam 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 and efficacy 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 completion of enrollment and
number of patients enrolled in our Phase 3 studies; our current
expectations regarding timing of and the target patient enrollment
numbers for our Phase 3 studies; expected data or clinical results
to be learned from our Phase 3 studies; the design, scope, conduct,
continuation, completion, intended purpose, or future results of
our Phase 3 program of simufilam in patients with Alzheimer's
disease; any findings or recommendations by the DSMB relating to
the interim safety of simufilam in our on-going Phase 3 clinical
trials; the treatment of patients with Alzheimer’s disease
dementia; comments made by our employees regarding simufilam, drug
effect, safety, and the treatment of Alzheimer’s disease; the
continued development of simufilam; and potential benefits, if any,
of our product candidates. These statements may be identified by
words such as “may,” “anticipate,” “believe,” “could,” “expect,”
“look forward,” “would”, “forecast,” “intend,” “plan,” “possible,”
“potential,” and other words, phrases, and terms of similar
meaning.
Simufilam is our investigational product
candidate. Its safety, efficacy or science has not reviewed or
approved by any regulatory authority in any jurisdiction and its
desirable clinical attributes, if any, 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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