Cassava Sciences, Inc. (Nasdaq: SAVA) today announced results of an
interim analysis from an open-label study of simufilam, its lead
drug candidate for the treatment of Alzheimer’s disease. Patients’
cognition and behavior scores both improved following six months of
simufilam treatment, with no safety issues.
In a clinical study funded by the National
Institutes of Health and conducted by Cassava Sciences, six months
of simufilam treatment improved cognition scores by 1.6 points on
ADAS-Cog11, a 10% mean improvement from baseline to month 6. In
these same patients, simufilam also improved dementia-related
behavior, such as anxiety, delusions and agitation, by 1.3 points
on the Neuropsychiatric Inventory, a 29% mean improvement from
baseline to month 6.
Alzheimer’s is a progressive disease. Over time,
a patient’s cognition will always worsen. “Experience based on
longitudinal studies of ambulatory patients with mild to moderate
Alzheimer’s disease suggest that scores on ADAS-cog decline by 6 -
12 points per year”, according to FDA’s Prescription Information
sheet for ARICEPT® (donepezil), a drug approved for the treatment
of dementia of the Alzheimer’s type1.“We could not be more pleased
with these interim results,” said Remi Barbier, President &
CEO. “We would have been satisfied to show simufilam stabilizes
cognition in patients over 6 months. An improvement in cognition
and behavior tells us this drug candidate has potential to provide
lasting treatment effects for people living with Alzheimer’s
disease. It’s an exciting development.”
The safety profile of simufilam in the interim
analysis was consistent with prior human studies. There were no
drug-related serious adverse events. Adverse events were mild and
transient.
“Today’s data once again suggests simufilam
could be a transformative, novel therapeutic,” added Nadav
Friedmann, PhD, MD, Chief Medical Officer. “It appears the drug’s
unique mechanism of action has potential to provide a treatment
benefit following 6 months of dosing.”
About the Interim
AnalysisCassava Sciences’ on-going, one-year, open-label,
multi-center study is evaluating the long-term safety and
tolerability of simufilam 100 mg twice daily in 100 patients with
mild-to-moderate Alzheimer’s disease. This study was initiated
March 2020 and is now approximately 80% enrolled. Today’s
pre-planned interim analysis summarizes clinical data at the midway
point of enrollment, i.e., the first 50 patients who have completed
at least 6 months of drug treatment.
ADAS-Cog (Alzheimer's Disease Assessment
Scale-Cognitive Subscale) is a standard test for assessing changes
in cognition in Alzheimer’s disease trials. NPI (Neuropsychiatric
Inventory) is a widely used tool for measuring changes in
dementia-related behavior. The Mini-Mental State Exam (MMSE) is a
widely used test of cognitive function among the elderly. The
interim analysis shows mean baseline scores of 15.5 on ADAS-Cog11,
4.5 on NPI and 22.1 on MMSE.
Much of the value of the open-label study is to
gain data to support simufilam’s long-term safety profile in
patients. Interim efficacy data from an open-label study has
limitations compared to efficacy data from a fully completed,
large, randomized controlled clinical trial, or from a fully
enrolled open-label study. However, prior clinical research in
Alzheimer’s disease conducted by other sponsors can serve as a
contextual reference for estimates of an expected rate of decline
in cognition in placebo patients:
- In 2019, a
randomized controlled trial of aducanumab (Biogen) was conducted in
>1,000 patients with early Alzheimer’s disease.2 In this Phase 3
study (EMERGE), patients on placebo showed a mean decline in
cognition of approximately 1.4 points on ADAS-Cog13, a 6.3%
decline, from baseline to month 6. Mean baseline ADAS-Cog13 score
was 22.2. Mean baseline MMSE was 26.4.
- A randomized
controlled study of ARICPET® (donepezil, Eisai) was conducted in
>400 patients with mild-to-moderate Alzheimer’s disease.3 In
this Phase 3 study, patients on placebo showed a mean decline in
cognition of approximately 1.9 points on ADAS-Cog, a 7.3% decline,
from baseline to week 24. Mean baseline ADAS-Cog score was 26. MMSE
range was 10-26.
Next StepsCassava Sciences
believes today’s data and prior clinical results support advancing
simufilam into a Phase 3 clinical program in Alzheimer’s disease.
Initiation of a Phase 3 trial remains on schedule for 2nd half
2021.
Cassava Sciences and the U.S. Food and Drug
Administration (FDA) recently concluded a successful end-of-phase 2
(EOP2) meeting for the simufilam drug development program. Details
of the EOP2 meeting will be announced Q1 2021 after official FDA
meeting minutes are finalized.
Based on today’s results and inbound demand from
Alzheimer’s patients and their caregivers, the enrollment target
for the open-label study will be increased by up to 50 additional
patients, to a total target of approximately 150 patients. The
Company is also in discussions with its scientific and clinical
advisors about other potential enhancements to the open-label
program.
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 2019.4 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.5About 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 OfficerCassava
Sciences, Inc.eschoen@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; inherent limitations of the ADAS-Cog and
NPI testing batteries; 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; 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.
This news release may also contain statistical
data and drug information based on independent industry
publications or other publicly available information. We have not
independently verified the accuracy or completeness of the data
contained in these publicly available sources of data and
information. Accordingly, we make no representations as to the
accuracy or completeness of such data or information. You are
cautioned not to give undue weight to such data.
1 Source:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf
(2018)2 Source: Biogen, EMERGE Phase III study, slide 24,
https://investors.biogen.com/static-files/8e58afa4-ba37-4250-9a78-2ecfb63b1dcb (2020)3
Source:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf (2018)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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