Cassava Sciences, Inc. (Nasdaq: SAVA) announced positive clinical
data today from an interim analysis of an open-label study with
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
cognition in Alzheimer’s patients, with no safety issues. Simufilam
improved cognition scores 3.0 points on ADAS-Cog11, an 18% mean
improvement, baseline to month 9 (p<0.001). This interim
analysis summarizes clinical data from the first 50 patients with
mild-to-moderate Alzheimer’s disease who completed 9 months of
open-label simufilam treatment.
Cassava Sciences believes today’s data is the
first report of significant cognitive improvements at 9 months that
also track with robust improvements in biomarkers in patients with
Alzheimer’s.
“We are very pleased with the overall
consistency of data,” said Remi Barbier, President & CEO.
“Simufilam improved cognition, biomarkers and behavior, a
triple-win for study participants. These clinical data combined
with a clean safety profile and easy oral administration suggest
highly encouraging and durable treatment effects for people living
with Alzheimer’s disease.”
Alzheimer’s is a progressive disease. Cognition
will always decline over time. In patients with mild-to-moderate
Alzheimer’s disease, cognition scores decline over 4 points on
ADAS-Cog over 9 months with over 90% certainty, as reported by the
science literature1.
Simufilam improved ADAS-Cog scores in 66% of
patients at 9 months. An additional 22% of patients declined less
than reported in the science literature at 9 months. Cognition
outcomes suggest simufilam’s treatment effects were
broad-based.
Alzheimer’s is often accompanied by behaviors
disorders, such as anxiety, agitation or delusions. These may
become more frequent as disease progresses. Simufilam reduced
dementia-related behavior at 9 months on the Neuropsychiatric
Inventory (NPI), a clinical tool widely used to measure changes in
dementia-related behavior.
- At baseline, 34%
of study subjects had no neuropsychiatric symptoms.
- At month 6, 38%
of study subjects had no neuropsychiatric symptoms.
- At month 9, over
50% of study subjects had no neuropsychiatric symptoms.
The safety profile of simufilam in the interim
analysis is consistent with prior human studies. There were no
drug-related serious adverse events. Adverse events were mild and
transient.
“Today’s data with simufilam suggests disease
modification,” added Nadav Friedmann, PhD, MD, Chief Medical
Officer. “It appears the drug’s unique mechanism of action has
potential to provide transformative treatment benefits following 9
months of dosing.”
In February 2021, Cassava Sciences reported that
simufilam improved cognition scores by 1.6 points on ADAS-Cog11, a
10% improvement, following six months of open-label treatment.
This press release is contemporaneous with
another press release titled, “Cassava Sciences Announce Positive
Biomarker Data with Simufilam in Alzheimer’s Disease”, which
reports simufilam significantly improved all measured biomarkers of
disease, neurodegeneration and neuroinflammation (p<0.00001)
following 6 months of open-label treatment.
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 is
advancing simufilam into a Phase 3 clinical program in Alzheimer’s
disease. The Phase 3 program with simufilam plans to enroll over
1,500 patients with mild-to-moderate Alzheimer’s disease. Study
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 2050.2 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.comor (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 Disease Progression Meta-analysis Model in Alzheimer’s disease
(Ito, et al., Pfizer Global Research), Alzheimer’s & Dementia 6
(2010) 39-53
2 Alzheimer's Disease International, Dementia
Statistics, available on-line.
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