Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company
focused on Alzheimer’s disease, today announced a mid-year update
that highlights clinical development progress and provides guidance
on upcoming data releases for simufilam and SavaDx. Simufilam is
Cassava Sciences’ lead drug candidate to treat Alzheimer’s disease;
SavaDx is an investigational diagnostic candidate to detect
Alzheimer’s with a simple blood test.
“Patients with Alzheimer’s want clear and
present evidence of drug efficacy,” said Remi Barbier, President
& CEO. “The recent regulatory approval of a new drug for
Alzheimer’s was a bit of a donnybrook over this very topic. Our
clinical strategy with simufilam is to show real-world safety and
efficacy by conducting both, randomized controlled trials, and an
on-going open-label study. Ideally, biomarker and cognition data
from our studies converge and result in health benefits for
patients.”
Clinical progress across Cassava Sciences’
product portfolio is summarized below.
Update on Open-label Study with
SimufilamIn 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 biomarker measurements
from baseline to Month 6 on a cohort of 25 study subjects, and
baseline to Month 12 on another cohort of 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 initiation of the Company’s Phase 3 pivotal program of
simufilam.
Guidance on Clinical Data
ReleaseCassava Sciences plans to announce results of an
interim analysis on safety and cognition for the first 50 subjects
to complete 9 months of open-label drug treatment. These cognition
data will be presented at the 2021 Alzheimer’s Association
International Conference (AAIC) in Denver, CO, the week of July
26-30th. The scientific committee of AAIC has invited the Company’s
scientists to present these data as an oral presentation.
Cassava Sciences will also present at AAIC
biomarker data from the open-label study, including:
- Biomarkers of Alzheimer’s disease:
amyloid beta42, total tau, P-tau181.
- Biomarkers of neurodegeneration:
neurogranin, neurofilament light chain (NfL).
- Biomarkers of neuroinflammation:
YKL-40, sTREM2 and HMGB1.
Biomarker data were analyzed from cerebrospinal
fluid (CSF) collected from twenty-five study subjects who underwent
a small volume lumbar puncture at baseline and again after
completing 6 months of open-label drug treatment.
Update on the Cognition Maintenance
Study (CMS)In May 2021, Cassava Sciences initiated a
double-blind, randomized, placebo-controlled study in patients with
Alzheimer’s disease called the Cognition Maintenance Study (CMS).
Patients who previously completed at least one year of open-label
treatment with simufilam qualify to enroll in the CMS. Study
subjects are randomized (1:1) to simufilam or placebo for six
months. The CMS is designed to compare simufilam’s effects on
cognition in Alzheimer’s patients who continue with drug treatment
versus patients who discontinue drug treatment. The target
enrollment for the CMS is 100 subjects or more; as of mid-June,
approximately 30 subjects were enrolled.
Update on the Phase 3 Clinical
ProgramCassava Sciences plans to initiate a Phase 3
program of simufilam in Alzheimer’s disease in the second half of
2021. A clinical research organization (CRO) has been selected and
will be publicly announced shortly. Large-scale, cGMP drug
production capabilities are in-place to support the Phase 3
clinical program.
Cassava Sciences’ Phase 3 program consists of
two double-blind, randomized, placebo-controlled studies in
patients with mild-to-moderate Alzheimer’s disease.
The first Phase 3 study is designed to evaluate
symptomatic improvement in Alzheimer’s disease. The goal is to
demonstrate improved cognition and daily function in subjects
treated with simufilam compared to baseline and to placebo.
Approximately 600 subjects will be enrolled, randomized (1:1) to
simufilam 100 mg or placebo BID, and treated for 12 months.
Efficacy endpoints are ADAS-Cog, a cognitive scale, and ADCS-ADL, a
scale of daily function.
The second Phase 3 study is designed to evaluate
disease-modifying effects of simufilam in Alzheimer’s disease. The
goal is to demonstrate a slower rate of decline in cognition and
daily function in subjects treated with simufilam compared to
placebo. Approximately 1,000 subjects will be enrolled, randomized
(1:1:1) to simufilam 100 mg, 50 mg or placebo BID, and treated for
18 months. Efficacy endpoints are ADAS-Cog and ADCS-ADL.
Update on SavaDxSavaDx is an
investigational diagnostic candidate to detect Alzheimer’s disease
with a simple blood test. SavaDx was evaluated for its ability to
detect treatment effects of simufilam versus placebo in a
randomized, controlled study completed in 2020. This was a Phase 2b
study that enrolled 64 patients with Alzheimer’s disease. The
SavaDx clinical dataset will be presented at AAIC the week of July
26-30th.
Update on Corporate OutlookAs
of March 31, Cassava Sciences had approximately $282 million in
cash. This affords Cassava Sciences a financial runway to support
the Phase 3 clinical development program of simufilam.
In addition, in May 2021, Cassava Sciences
announced a new $2.7 million research grant award from the National
Institutes of Health (NIH). This NIH research grant is intended to
fund clinical readiness activities in support of the upcoming Phase
3 program with simufilam.
Net cash use for operations for full-year 2021
is still expected to be approximately $20 to $25 million, with
variance depending on how quickly new clinical study sites are
onboarded for the Phase 3 program with simufilam and the study’s
rate of patient enrollment.
To support current and future expected clinical
progress, Cassava Sciences continues to grow its internal team,
while also continuing to rely on an external network of industry
experts and scientific advisors. In 2021, the Company expects to
significantly increase its square footage of office and R&D
space to accommodate growth in its operations.
Cassava Sciences is also committed to monitor
and, as appropriate, to upgrade its policies and procedures around
board-level governance, sustainability and societal goals as it
continues to execute its corporate and clinical strategies. To help
with such efforts, a new Board member, Richard (Rick) Barry was
recently appointed to the Board of Directors.
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).
About SavaDxSavaDx is Cassava
Sciences’ investigational diagnostic to detect Alzheimer’s disease.
The goal of SavaDx is to make the detection of Alzheimer’s as
simple as getting a blood test, possibly years before the
appearance of any overt clinical symptoms. SavaDx is substantially
funded by a peer-reviewed research grant award 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 Disease
Alzheimer’s disease is a progressive brain disorder that destroys
memory and thinking skills. Currently, there are no drug therapies
to halt Alzheimer’s disease, much less reverse its course.
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 Officer
eschoen@CassavaSciences.com
(512) 501-2450
1 Alzheimer's Disease International, Dementia Statistics,
available on-line and accessed June 20, 2021.
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 Company’s anticipated data
presentations at AAIC; expectations regarding convergence of
biomarker and cognition data, and treatment benefits of simufilam;
the Company’s execution on its strategy to initiate a Phase 3
clinical program in Alzheimer’s disease in 2021; expected cash use
in future periods and ability of existing cash to support the Phase
3 clinical development program of simufilam; planned growth in
personnel and facilities; and Mr. Barry’s anticipated contributions
to the Board of Directors. 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.
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