Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biopharmaceutical company focused on Alzheimer’s disease, today
announced that clinical results of its Phase 2b study of sumifilam
have been selected as a late-breaking oral presentation by the 13th
international conference on Clinical Trials on Alzheimer’s Disease
(CTAD). CTAD is a prestigious annual conference focused on
Alzheimer’s research and development and takes place this year as a
virtual event on November 4-7th, 2020. Members of CTAD’s scientific
committee select research abstracts for late-breaking, oral
presentation based on medical and scientific significance, quality
of data and methodology.
Details of Late-breaking Presentation:
Title:
“Sumifilam (PTI-125) Significantly
Improves Eleven CSF Biomarkers in A Randomized, Placebo-Controlled,
One-Month Clinical Trial in Alzheimer’s Disease
Patients.”
Presentation
Type: |
Late-Breaking,
Oral Presentation (LB21) |
Presenter: |
Lindsay H. Burns, PhD, SVP Neuroscience, Cassava Sciences |
Date/Time: |
November 7, 2020, 11:10 am EST |
Venue: |
Virtual conference |
Cassava Sciences’ late-breaking CTAD
presentation will be made available on the day of the presentation
on its corporate website (www.CassavaSciences.com) in the
‘Investors’ page.
Cassava Sciences recently announced final
results of a Phase 2b study with sumifilam, its lead drug
candidate, in Alzheimer’s disease. In a clinical study funded by
the National Institutes of Health (NIH), Alzheimer’s patients
treated with 50 mg or 100 mg of sumifilam twice-daily for 28 days
showed statistically significant (p<0.05) improvements in
biomarkers of disease pathology, neurodegeneration and
neuroinflammation, versus Alzheimer’s patients who took placebo. In
addition, Alzheimer’s patients treated with sumifilam showed
improvements in validated tests of episodic memory and spatial
working memory, versus patients on placebo (Effect Size 17-46%).
Cognitive improvements correlated most strongly (R2=0.5) with
decreases in levels of P-tau181.
Phase 2b Study ConclusionsA
small, well-controlled study of sumifilam showed promising
treatment effects in patients with mild-to-moderate Alzheimer’s
disease. In this study, sumifilam treatment over 28 days improved
an entire panel of validated biomarkers of Alzheimer’s disease,
decreased measurements of neuroinflammation, showed a 98% responder
rate, was safe and well-tolerated, and appears to benefit
cognition. Importantly, the data are consistent with prior clinical
and preclinical results, the drug’s mechanism of action and over 10
years of basic research.
Ongoing
Open-label StudyCassava
Sciences is currently conducting a long-term, open-label,
multi-center study of sumifilam 100 mg twice-daily for 12 months.
The study’s target enrollment is approximately 100 patients with
mild-to-moderate Alzheimer’s disease. This study is over 50%
enrolled.
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 SumifilamSumifilam 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
sumifilam 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. The Company is also developing
an investigational diagnostic, called SavaDx, to detect Alzheimer’s
disease with a simple blood test.
Sumifilam 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. 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.
Patent protection in this area currently runs beyond 2037, plus
extensions, and includes seven issued patents and related patent
filings and applications.
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
Please Contact:Eric Schoen, Chief
Financial Officereschoen@CassavaSciences.com(512) 501-2450
Cassava Sciences’ Phase 2b study of sumifilam in
Alzheimer’s disease was funded by clinical research grant #AG060878
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 press release contains
“forward-looking statements” for purposes of the Private Securities
Litigation Reform Act of 1995 (the Act). Cassava Sciences claims
the protection of the Safe Harbor for forward-looking statements
contained in the Act. All statements other than statements of
historical fact contained in this press release including, but not
limited to, statements regarding the status of current and
future clinical studies with sumifilam; the interpretation of
results of our Phase 2 clinical studies including cognition data
and plans to discuss clinical results at CTAD 2020; potential
health benefits, if any, of changes in levels of biomarkers; verbal
commentaries made by Cassava Sciences’ employees and scientific
advisors; and potential benefits, if any, of the Company’s product
candidates for Alzheimer’s disease are forward-looking
statements. Such statements are based largely on the Company’s
current expectations and projections about future events. Such
statements speak only as of the date of this press 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 Cassava Sciences’ Annual Report on Form 10-K for the
year ended December 31, 2019 and future reports to be filed with
the SEC. In light of these risks, uncertainties and assumptions,
the forward-looking statements and events discussed in this press
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, the
Company disclaims any intention or responsibility for updating or
revising any forward-looking statements contained in this press
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.
1,2 Source: Alzheimer’s Association. 2019
Alzheimer’s Disease Facts and Figures. Available online at:
https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
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