Cassava Sciences Completes Patient Dosing in a Randomized Controlled Trial of Simufilam in Alzheimer’s Disease
11 Maio 2023 - 10:15AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company, today announced the completion of patient
dosing in a 6-month, randomized controlled trial of simufilam in
over 125 patients with Alzheimer’s disease. This trial is known as
the Cognition Maintenance Study (CMS). Simufilam is Cassava
Sciences’ investigational oral drug treatment for Alzheimer’s
disease dementia.
“We all know that Phase 3 studies, if
successful, provide evidence of efficacy,” said Remi Barbier,
President & CEO. “Our Cognition Maintenance Study addresses a
flip side of the drug efficacy question: What happens when
Alzheimer’s patients who were taking simufilam for a year stop
taking the drug for six months? Differences that emerge between the
group of patients that continued to take simufilam versus the group
of patients randomized to placebo may suggest evidence of
simufilam’s efficacy.”
The CMS is a randomized, double-blind,
placebo-controlled, 6-month trial designed to evaluate the safety
and efficacy of simufilam in patients with mild-to-moderate
Alzheimer’s disease dementia. The CMS follows a randomized
withdrawal study design. To enroll in the CMS, patients must have
previously completed 12 months or more of open-label treatment with
simufilam. Enrollment in the CMS was open to all patients who
responded to open-label treatment, as well as to all patients who
had no apparent response to open-label treatment.
CMS study participants were randomized (1:1) to
simufilam or placebo. The primary outcome measures are safety and
change in cognition scores (ADAS-Cog) over 6 months in over 125
patients who completed dosing. The CMS dataset remains locked and
blinded. After unlocking, the dataset will be analyzed by outside
biostatisticians. Subgroup analyses may include patients by stage
of disease, prior response to open-label treatment, baseline scores
or other crucial shared characteristics.
Cassava Sciences expects to announce CMS
top-line data in Q3 2023.
About SimufilamSimufilam is a
novel drug candidate designed to treat and slow the progression of
Alzheimer’s disease. Simufilam binds tightly to an altered
conformation of the filamin A protein (FLNA) that is present in the
brain of the Alzheimer’s patient and is critical to the toxicity of
Aβ42. Simufilam is wholly owned by Cassava Sciences, without
royalty or payment obligation 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 novel
science is based on stabilizing—but not removing—a critical protein
in the brain. Our product candidates have not been approved by any
regulatory authority, and their safety, efficacy or other desirable
attributes have not been established. For more information, please
visit our website: 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,
that may include but are not limited to: our clinical strategy and
plans; the size, scope and design of our Cognition Maintenance
Study (CMS) and its likelihood of success; our use of a randomized
withdrawal study design in the CMS; the expected interpretation of
clinical data generated in our CMS; any actual or assumed standards
of drug efficacy in clinical trials, including Phase 3 studies; the
timing of top-line clinical results of the CMS; any expected
clinical results of Phase 3 studies; the treatment of people with
Alzheimer’s disease dementia; the safety or efficacy of simufilam
in people with Alzheimer’s disease dementia; verbal commentaries
made by our employees; and potential benefits, if any, of the our
product candidates. These statements may be identified by words
such as “may,” “anticipate,” “believe,” “could,” “expect,”
“forecast,” “intend,” “plan,” “possible,” “potential,” and other
words and terms of similar meaning.
Simufilam and SavaDx are our investigational
product candidates. They are not approved by any regulatory
authority in any jurisdiction and their safety, efficacy or other
desirable attributes have not been established in patients.
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.
Clinical results and analyses of our CMS study should not be relied
upon as predictive of Phase 3 studies or any other study. Top-line
clinical results from our CMS may not be indicative of full study
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, 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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