Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company
focused on Alzheimer’s disease, today announced the publication of
new research that confirms the biological activity of simufilam.
Simufilam is Cassava Sciences’ novel drug candidate for people with
Alzheimer’s disease dementia and is currently under evaluation in a
pair of global Phase 3 clinical trials.
Researchers at the Cochin Institute (Paris,
France) used a highly precise cell-based assay to show that
simufilam interrupts amyloid binding to the α7 nicotinic
acetylcholine receptor (α7nAChR). Cassava Sciences believes this
protein interaction underlies simufilam’s mechanism of action in
Alzheimer’s disease. The research appears in a special issue of
International Journal of Molecular Sciences, a peer-reviewed
scientific publication.
“Four academic institutions have now generated
data in support of the biological activity of simufilam,” said Remi
Barbier, President & CEO. “They can’t all be wrong.”
“Today’s data are an elegant confirmation of
simufilam’s mechanism of action,” said Lindsay Burns, PhD, VP of
Neuroscience at Cassava Sciences and co-author on the publication.
“They show that simufilam potently disrupts a known pathological
action of amyloid β using a robust and highly sensitive assay based
on a technique called TR-FRET.”
Journal: |
International Journal of Molecular Sciences, special issue: |
|
Neurodegenerative Disease: From Molecular Basis to Therapy |
|
|
Title: |
Simufilam Reverses Aberrant Receptor Interactions of Filamin A in
Alzheimer’s Disease |
|
|
Access: |
Available on-line, and expected to be posted shortly in the
publication section of www.CassavaSciences.com |
Summary of New ResearchA team
of researchers led by Dr. Ralf Jockers at the Cochin Institute
(Paris, France) used an amyloid binding assay to measure the
ability of simufilam to prevent amyloid β from binding to the α7
nicotinic acetylcholine receptor (α7nAChR). Their study showed that
simufilam potently reduced amyloid β binding to α7nAChR. This new
data is consistent with prior research showing that simufilam
prevents amyloid β from binding to α7nAChR. The Cochin Institute is
a biomedical research center affiliated with public research
organizations (Inserm and CNRS) and the University of Paris,
France.
Dr. Jockers and his team developed their amyloid
binding assay as a means of determining whether ‘a novel generation
of [Alzheimer’s disease] drug candidates could effectively
interrupt the high-affinity binding of amyloid β to α7nAChR.’1 The
cell-based assay uses time-resolved fluorescence resonance energy
transfer (TR-FRET) to accurately measure the degree to which a drug
candidate such as simufilam can inhibit amyloid β binding to
α7nAChR. Testing several concentrations of a drug in this assay
allows calculation of its potency. TR-FRET is different from any
prior technique used by other academic collaborators to show the
biological activity of simufilam.
The Cochin Institute is the fourth academic
institution to produce data supporting the biological activity of
simufilam on FLNA. Simufilam was developed by Cassava Sciences in
collaboration with researchers at CUNY School of Medicine who first
showed the effects of simufilam on FLNA and on the signaling
pathways of amyloid β in Alzheimer’s disease. In 2020, Dr.
Angelique Bordey of Yale University published data showing that
simufilam reduced seizure frequency and alleviated neuronal
abnormalities in mice with a form of epilepsy associated with FLNA
overexpression. In 2023, Dr. Erika Peverelli of the University of
Milan showed that simufilam reduced FLNA phosphorylation and
enhanced the effects of a pituitary cancer treatment in experiments
using both patient tumor biopsies and rat cell lines.
On-going Phase 3 Studies with
SimufilamCassava Sciences is evaluating simufilam oral
tablets for Alzheimer’s disease dementia in two global Phase 3
clinical studies. These are randomized, double-blind,
placebo-controlled trials. The Phase 3 program aims to enroll a
total of approximately 1,750 patients with mild-to-moderate
Alzheimer’s disease who also meet other study eligibility criteria.
Patient enrollment is expected to be completed for both Phase 3
studies by yearend 2023. Both Phase 3 studies have received a
Special Protocol Assessment (SPA) from the U.S. Food and Drug
Administration.
About SimufilamSimufilam is
Cassava Sciences’ proprietary, small molecule (oral) drug candidate
for the treatment of Alzheimer’s disease dementia. Unlike
monoclonal antibody treatments for Alzheimer’s disease, simufilam
does not purport to directly remove amyloid β from the brain.
Instead, simufilam binds to altered filamin A (FLNA), a
receptor-associated protein that amyloid β requires to bind to
α7nAChR. By preventing amyloid β from signaling via α7nAChR and
other receptors, simufilam reduces the neurodegeneration and
neuroinflammation characteristic of Alzheimer’s disease.
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 is a clinical-stage biotechnology
company based in Austin, Texas. Our mission is to detect and treat
neurodegenerative diseases, such as Alzheimer’s disease. For more
information, please visit: https://www.CassavaSciences.com
DisclosuresCassava Sciences’
product candidates have not been approved by any regulatory
authority or health agency, and their safety or efficacy have not
been established in humans. The TR-FRET research was conducted by
the Cochin Institute and funded by Cassava Sciences. The Cochin
Institute has no financial benefit tied to the outcome of the
research. The contents of this press release are solely the
responsibility of Cassava Sciences and do not represent the views
of the National Institutes of Health, the Cochin Institute or any
other research or governmental agency.
For More Information Contact: Eric Schoen,
Chief Financial Officer(512) 501-2450 or
ESchoen@CassavaSciences.com
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: our current expectations regarding
the target patient enrollment numbers for our Phase 3 studies;
comments made by our employees regarding the evaluation of
simufilam in Phase 3 trials of Alzheimer’s disease; the mechanism
of action of simufilam, or any lab methods used to demonstrate such
effects; 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 only a small number of research and development programs result
in regulatory approval and commercialization of a product. Our
interim data and analyses should not be relied upon as predictive
of full study results for any of our studies. Our clinical results
from earlier-stage clinical trials may not be indicative of full
study 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, 2021, 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 Cecon E, Dam J, Luka M,
Gautier C, Chollet AM, Delagrange P, Danober L, Jockers R.
Quantitative assessment of oligomeric amyloid β peptide binding to
α7 nicotinic receptor. Br J Pharmacol. 2019
Sep;176(18):3475-3488.
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