MRI Data Suggest Simufilam is Not Associated with Amyloid-related Imaging Abnormalities (ARIA)
25 10월 2023 - 10:15PM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company, today announced a potentially significant
safety finding based on interim magnetic resonance imaging (MRI)
brain data from Alzheimer’s patients who are enrolled in a Phase 3
clinical trial of simufilam. The MRI data suggest simufilam is not
associated with treatment-emergent amyloid-related imaging
abnormalities, or ARIA. MRIs were all analyzed for ARIA by
board-certified neuroradiologists.
ARIA is a medical term used to describe a
spectrum of brain MRI imaging abnormalities, such as edema and
brain bleeds. ARIA is also a known risk factor for Alzheimer’s
patients taking the class of drugs known as monoclonal antibodies
directed against beta amyloid. In contrast to such class of drugs,
simufilam is Cassava Sciences’ small-molecule (oral) drug
candidate. Oral simufilam is currently in Phase 3 clinical testing
in patients with Alzheimer’s disease dementia.
The new safety finding is based on an
independent, interim neuroradiological evaluation of brain MRIs
taken at week 40 in a blinded sub-study of 180 Alzheimer’s patients
enrolled in Cassava Sciences’ on-going 76-week Phase 3 clinical
trial of simufilam in mild-to-moderate Alzheimer’s (NCT#05026177).
Final MRI data is expected at the conclusion of this Phase 3
study.
All Phase 3 clinical data remains blinded.
The MRI data and two other datasets will be
presented at the 16th Clinical Trials on Alzheimer's Disease (CTAD)
conference taking place in Boston, MA, October 24-27th, 2023:
- LP036:
“Interim MRI Safety Analysis from a 76-week Phase
3 Clinical Trial of Simufilam in Alzheimer’s Disease.”
Poster publication.
- LB23:
“Results of a Phase 2 Randomized Withdrawal Study of
Simufilam in Mild-to-moderate Alzheimer’s Disease.”
Late-breaking oral presentation by Suzanne Hendrix, PhD, Pentara
Corporation, Friday, Oct 27th, 3:30pm ET.
- LP107:
“Simufilam’s Primary Mechanism of Action Confirmed by
Time-resolved FRET.” Poster presentation.
Access to these presentations may be available
at CTAD in Boston or on-line at CTAD’s website, and are expected to
be posted shortly in the publication section of:
www.CassavaSciences.com
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 continuation of our Phase 3
clinical program; results of research relating to simufilam and to
the mechanism of action underlying simufilam; the treatment of
patients with Alzheimer’s disease dementia; the results and
potential clinical implications, if any, of blinded MRI data taken
from 180 Alzheimer’s patients enrolled in our 76-week Phase 3
clinical trial of simufilam; the risk of current or future findings
of treatment-emergent ARIA in our clinical program of simufilam;
comments made by our employees at CTAD or elsewhere regarding our
blinded MRI data, our science or simufilam and the treatment of
Alzheimer’s disease, or CTAD presentations #LP036, LB23 or LP107;
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 been 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.
Cassava Sciences (NASDAQ:SAVA)
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