Cassava Sciences, Inc. (Nasdaq: SAVA) today announced positive
biomarker data from an open-label study of simufilam, the Company’s
investigational drug for the treatment of Alzheimer’s disease.
In a clinical study funded by the National
Institutes of Health (NIH), simufilam significantly improved all
measured biomarkers in patients with Alzheimer’s disease following
6 months of open-label treatment. Biomarkers are objective
biological data. There are no placebo effects.
Cerebrospinal fluid (CSF) biomarkers of disease
pathology, t-tau and p-tau181, decreased 38% and 18%, respectively
(both p<0.00001). CSF biomarkers of neurodegeneration,
neurogranin and Nfl, decreased 72% and 55%, respectively (both
p<0.00001). CSF biomarkers of neuroinflammation, sTREM2 and
YKL-40, decreased 65% and 44% (both p<0.00001). CSF biomarker
data were collected from 25 patients with mild-to-moderate
Alzheimer’s disease who completed 6 months of simufilam treatment
in an on-going open-label study.
“Six months of simufilam treatment robustly
improved brain biomarkers,” said Remi Barbier, President & CEO.
“In this same study simufilam also improved cognition. These data
suggest simufilam has potential to provide durable treatment
effects for people living with Alzheimer’s.”
About Cerebrospinal
Fluid (CSF) BiomarkersA key objective of this analysis was
to measure changes in levels of biomarkers in patients before and
after 6 months of treatment with open label simufilam. Biomarker
data were analyzed from CSF collected from 25 patients with
mild-to-moderate Alzheimer’s disease who are enrolled in an
on-going open-label study and who agreed to undergo a lumbar
puncture at baseline and again after 6 months of treatment. All
bioanalyses were conducted blind by an outside lab. Simufilam
robustly improved all measured CSF biomarkers (all p-values are
baseline vs. 6-month levels by paired t-test):
Core markers of Alzheimer’s pathology are total
tau (T-tau), phosphorylated tau (P-tau181), and amyloid beta42
(Aβ42). In Alzheimer’s, tau levels are elevated and Aβ42 is
low.
- T-tau decreased 38%
(p<0.00001)
- P-tau181 decreased 18%
(p<0.00001)
- CSF Aβ42 increased 84%
(p<0.00001)
Elevated CSF levels of two proteins, neurogranin (Ng) and
neurofilament Light Chain (NfL) indicate neurodegeneration.
- Ng decreased 72% (p<0.00001)
- NfL decreased 55%
(p<0.00001)
Elevated levels of marker YKL-40 indicate neuroinflammation.
- YKL-40 decreased 44%
(p<0.00001)
sTREM2 is a biomarker of microglia-induced
neuroinflammation that has commanded substantial recent attention
from researchers for its role in Alzheimer’s and frontotemporal
dementia.
- sTREM2 decreased
65% (p<0.00001)
HMGB1 protein, is a damage-related protein
sometimes called a ‘danger molecule’ because it triggers additional
neuroinflammation and loss of neurons.
- HMGB1 decreased
53% (p<0.00001)
In February 2021, Cassava Sciences reported that
simufilam improved cognition scores by 1.6 points on ADAS-Cog11, a
10% mean improvement from baseline, following six months of
open-label treatment.
This press release is contemporaneous with
another press release titled, “Cassava Sciences Announces Positive
Cognition Data with Simufilam in Alzheimer’s Disease”, which
reports simufilam improved cognition scores by 3.0 points on
ADAS-Cog at 9 months (p<0.001).
About Today’s
Oral Presentation at AAICLindsay
Burns, Senior VP, Neuroscience at Cassava Sciences, is scheduled to
give a live podium presentation today at the Alzheimer’s
Association International Conference (AAIC) in Denver, CO and
virtually. Dr. Burns’ presentation is titled, “Encouraging Interim
Results at 9 Months from an Open-label Study of Simufilam in
Alzheimer’s Disease” (AAIC abstract #54395).
Today’s AAIC presentation can be accessed on the
‘Investors’ page of the Company’s website:
https://www.CassavaSciences.com
About the Open-label
StudyIn March 2020, Cassava Sciences initiated a
long-term, open-label study to evaluate simufilam in patients with
Alzheimer’s disease. This study is funded by a research grant award
from the National Institutes of Health (NIH). The open-label
study is intended to monitor the long-term safety and
tolerability of simufilam 100 mg twice-daily for 12 months or
longer in patients with Alzheimer’s disease. Another study
objective is to measure changes in cognition on ADAS-Cog, a
standard test of cognition in Alzheimer’s disease. The study
protocol has pre-specified interim analyses on safety and cognition
for the first 50 subjects who complete 6, 9 and 12 months of drug
treatment. The study protocol also specifies two biomarker
measurements: i) from baseline to Month 6 in 25 study subjects, and
ii) baseline to Month 12 in another 25 study subjects. The
open-label study has completed its target enrollment of 150
subjects. By physician and patient request, clinical sites may
continue to enroll additional subjects up through the upcoming
initiation of the Company’s Phase 3 pivotal program of
simufilam.
Next StepsCassava Sciences
believes clinical results support advancing simufilam into a Phase
3 clinical program in Alzheimer’s disease. Phase 3 program
initiation is scheduled for Fall 2021.
About SimufilamSimufilam
(sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that
restores the normal shape and function of altered filamin A (FLNA),
a scaffolding protein, in the brain. Altered FLNA in the brain
disrupts the normal function of neurons, leading to Alzheimer’s
pathology, neurodegeneration and neuroinflammation. The underlying
science for simufilam is published in peer-reviewed journals,
including Journal of Neuroscience, Neurobiology of Aging, Journal
of Biological Chemistry, Neuroimmunology and Neuroinflammation
and Journal of Prevention of Alzheimer’s Disease. Simufilam is
substantially supported by peer-reviewed research grant awards from
the National Institutes of Health (NIH).
Simufilam and SavaDx were both developed
in-house. 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 Alzheimer’s
DiseaseAlzheimer’s disease is a progressive brain disorder
that destroys memory and thinking skills. As of 2020, there were
approximately 50 million people worldwide living with dementia, a
figure expected to increase to 150 million by 2050.1 The annual
global cost of dementia is now above $1 trillion,
according to Alzheimer’s Disease International, a charitable
organization.
About Cassava Sciences,
Inc.Cassava Sciences’ mission is to discover and develop
innovations for chronic, neurodegenerative conditions. Over the
past 10 years, Cassava Sciences has combined state-of-the-art
technology with new insights in neurobiology to develop novel
solutions for Alzheimer’s disease. For more information, please
visit: https://www.CassavaSciences.com.
For More Information
Contact:Eric Schoen, Chief Financial
Officereschoen@CassavaSciences.com(512) 501-2450
Cassava Sciences’ open-label study of simufilam
in Alzheimer’s disease is funded by clinical research grant
#AG065152 from the National Institutes of Health (NIH/NIA).
The content of this press release is solely the
responsibility of Cassava Sciences and does not necessarily
represent the official views of the NIH/NIA.
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 treatment or diagnosis of
Alzheimer’s disease; the status of current and future clinical
studies with simufilam, including the interpretation of interim
analyses of open-label study results; plans to conduct additional
interim analyses of an open-label study and the timing thereof;
inherent limitations of the ADAS-Cog testing batteries;
expectations regarding convergence of biomarker and cognition data,
and treatment benefits of simufilam; our intention to initiate a
Phase 3 clinical program with simufilam and the timing, enrollment,
duration and other details thereof; verbal commentaries made by our
employees; 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.
Drug development involves a high degree of risk,
and historically only a small number of research and development
programs result in commercialization of a product. Clinical results
from our earlier-stage clinical trials may not be indicative of
full 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, the severity and duration of health care precautions
given the COVID-19 pandemic, any unanticipated impacts of the
pandemic 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, 2020 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.
_______________1 Alzheimer's Disease
International, Dementia Statistics, available on-line.
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