Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company developing product candidates for Alzheimer’s
disease, today announced significant program progress and expected
milestones for 2021.
“We started 2021 with tremendous momentum, led
by results of a 6-month interim analysis from an open-label study
of simufilam, our drug candidate for Alzheimer’s disease,” said
Remi Barbier, President & CEO. “I believe the rest of the year
may be equally exciting.”
Cassava Sciences’ strategic focus for 2021 is to
advance simufilam in a Phase 3 clinical program in Alzheimer’s
disease, to expand drug manufacturing capabilities in support of
the clinical program, and to continue to lead the Company to
deliver the full potential of its product portfolio.
Cassava Sciences’ 2021 Scientific and
Clinical OutlookCassava Sciences’ product portfolio
includes a small molecule drug for the treatment of Alzheimer’s
disease, called simufilam, and an investigational blood-based
diagnostic to detect and monitor the progression of Alzheimer’s
disease, called SavaDx.
Expected progress and key milestones in 2021
across Cassava Sciences’ product portfolio are summarized
below.
- Based on recent positive clinical
results and inbound demand from clinical sites, patients, and their
caregivers, Cassava Sciences plans to expand the size of the
ongoing open-label study of simufilam. The target enrollment will
be increased by up to 50 additional patients with mild-to-moderate
Alzheimer’s disease, for a total target enrollment of up to 150
patients.
- Cassava Sciences has enrolled
approximately 80 patients in the open-label study to date. To
accommodate increased enrollment, the Company plans to open new
clinical sites across the U.S. and Canada.
- Cassava Sciences expects to
announce results of a second interim analysis of the ongoing
open-label study when approximately 50 patients complete 12 months
of drug treatment. This second interim analysis is expected to
include clinical data around long-term safety, cognition and
Alzheimer’s-related behavior.
- Cassava Sciences plans to initiate
a 6-month, double-blind, randomized, placebo-controlled study in
patients with Alzheimer’s disease who complete at least one year of
open-label treatment with simufilam. This is a Cognition
Maintenance Study (CMS), in which patients who complete one year of
open-label treatment will subsequently be randomized (1:1) to
simufilam or placebo for six months. The CMS is designed to compare
simufilam’s effects on cognition and behavior in patients who
continue with drug treatment versus those who discontinue drug
treatment. For ethical and other reasons, patients who successfully
complete the six-month CMS will have the option to receive
open-label simufilam.
- Cassava Sciences’ clinical and
regulatory strategy for simufilam is progressing as planned. In
January 2021, the Company concluded a successful End-of-phase 2
(EOP2) meeting with the U.S Food and Drug Administration (FDA). The
purpose of the EOP2 was to gain general agreement around a Phase 3
program to treat Alzheimer’s disease dementia.
- As a result of the EOP2 meeting,
Cassava Sciences believes its clinical program for simufilam is
green-lighted to commence a large, Phase 3 clinical program in
patients with Alzheimer’s disease, pending official FDA meeting
minutes of the EOP2 meeting.
- Cassava Sciences plans to initiate
a Phase 3 program of simufilam in Alzheimer’s disease in the second
half of 2021.
- Cassava Sciences’ Phase 3 program
for simufilam consists of two large, double-blind, randomized,
placebo-controlled studies of simufilam in patients with
mild-to-moderate Alzheimer’s disease dementia. The Company expects
to announce details of its Phase 3 program in Q1 2021, pending
official FDA meeting minutes of the EOP2 meeting.
- Cassava Sciences’ first Phase 3
study will evaluate disease-modifying effects in Alzheimer’s
disease patients over 18 months. The goal of this study is to show
a slower rate of decline in cognition and daily function in
patients treated with simufilam, compared to patients treated with
placebo.
- Cassava Sciences’ second Phase 3
study will evaluate symptomatic improvement in Alzheimer’s disease
patients over 6 months. The goal of this study is to show
improvement in cognition and daily function in patients treated
with simufilam, compared to patients treated with placebo.
- Cassava Sciences believes its
manufacturing strategy is on-track to ensure sufficient drug supply
for a Phase 3 program, including both drug substance (i.e., active
ingredient) and drug product (i.e., oral tablets).
- Cassava Sciences expects to
conclude a long-term, commercial drug supply agreement for
simufilam with a contract manufacturing organization. The goal is
to ensure the integrity of the drug supply chain on a worldwide
basis, in compliance with FDA standards.
- Cassava Sciences expects to
initiate a validation study with SavaDx, its investigational
diagnostic for the detection of Alzheimer’s disease.
- Cassava Sciences is in discussions
with scientific and clinical advisors about potentially expanding
therapeutic indications for simufilam outside of Alzheimer’s
disease, but still within neurodegenerative conditions.
Other Expected Milestones and
Announcements for 2021
- Cassava Sciences expects to
announce publication of Phase 2b results in a peer-reviewed
technical journal.
- Net cash use for full-year 2021 is
expected to be in the range of $20 to $25 million, depending on
enrollment rates in its clinical programs and other factors. On
December 31, 2020, unaudited cash and cash equivalents were
approximately $93 million.
Slide DeckA copy of Cassava
Sciences’ latest corporate presentation is available on its website
https://www.CassavaSciences.com, under the Investors/Presentations
page.
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. In the
U.S. alone, approximately 5.8 million people are currently living
with Alzheimer’s disease, and approximately 487,000 people age 65
or older developed Alzheimer’s in 2019.1 The number of people
living with Alzheimer’s disease is expected to grow dramatically in
the years ahead, resulting in a growing social and economic
burden.2
About SimufilamSimufilam 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.
Cassava Sciences is also developing an
investigational diagnostic, called SavaDx, to detect Alzheimer’s
disease with a simple blood test.Simufilam and SavaDx were both
developed in-house. Both product candidates are substantially
funded by peer-review research grant awards from the National
Institutes of Health (NIH). 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 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.
Cassava Sciences Safe
HarborThis 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: our strategy and plans; the treatment of Alzheimer’s
disease; the status of current and future clinical studies with
simufilam, including the interpretation of an interim analysis of
open-label study results; planned enrollment and other changes to
the open-label program; our intention to initiate a Phase 3
clinical program with simufilam in 2nd half 2021; results of our
EOP2 meeting with FDA and the timing of further announcements; our
ability to manufacture drug supply for a Phase 3 program and to
enter into a long-term commercial drug supply agreement; the timing
of validation studies with SavaDx; our ability to expand
therapeutic indications for simufilam outside of Alzheimer’s
disease; expected cash use in future periods; plans to publish
results of a Phase 2b study in a peer-reviewed journal; 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. 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. Our clinical results from
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, 2019 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.
4, 5 Source: Alzheimer’s Association. Disease Facts and Figures.
https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
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