Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced that it has been awarded a new $2.5 million research
grant award from the National Institutes of Health (NIH). This new
research grant will support the on-going clinical evaluation of
PTI-125, the Company’s lead investigational drug. PTI-125 has a
unique mechanism of action that seeks to improve both
neurodegeneration and neuroinflammation in patients with
Alzheimer’s disease.
The NIH's National Institute on Aging (NIA)
awarded Cassava Sciences this research grant award following an
in-depth, peer review of PTI-125. Peer review, one of the gold
standards of science, is a process where independent, outside
scientists evaluate the merits of new research. NIH research grants
are paid out in increments based on milestone-based technical
progress.
“We are once again most grateful to the NIH for
its support of the clinical evaluation of PTI-125,” said Remi
Barbier, President & CEO of Cassava Sciences. “This new
research grant award will support our on-going open-label study of
PTI-125 in patients with Alzheimer’s disease.”
About the On-going Open-label
StudyIn March 2020, Cassava Sciences announced the
initiation of an open-label, multi-center clinical study of PTI-125
at 100 mg twice-daily for 12 months. The target enrollment is
approximately 100 patients with mild-to-moderate Alzheimer’s
disease.
About the Completed Phase 2b
StudyIn March 2020, Cassava Sciences announced the
completion of a Phase 2b study of PTI-125 in mild-to-moderate
Alzheimer’s patients. In this blinded, randomized,
placebo-controlled, multi-center, multi-dose study, 64 study
participants received PTI-125 100 mg, 50 mg or matching placebo,
twice-daily, for 28 continuous days. The primary endpoint is
improvement in levels of biomarkers of disease. Biomarker analysis
is on-going.
Cassava Sciences expects to announce top-line
results for its completed Phase 2b study approximately mid-year
2020.
About PTI-125Cassava Sciences is developing this
lead therapeutic product candidate for the treatment of Alzheimer’s
disease. PTI-125 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
disease pathology, neurodegeneration and neuroinflammation. PTI-125
seeks to simultaneously improve both neurodegeneration and
neuroinflammation. The underlying science is published in
peer-reviewed scientific journals, including Journal of
Neuroscience, Neurobiology of Aging, Journal of Biological
Chemistry 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.
About Alzheimer’s
DiseaseAlzheimer’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 the National Institute on Aging
(NIA) of the NIHNIA, one of the Institutes of the NIH,
leads a broad scientific effort to understand the nature of aging
and is the primary Federal agency supporting and conducting
Alzheimer's disease research.
For more information about NIA, please visit:
https://www.nia.nih.gov/health/alzheimers
About Cassava Sciences
(Nasdaq: SAVA)The mission of Cassava Sciences, Inc. is to
detect and treat neurodegenerative diseases, such as Alzheimer’s
disease. 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. 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.
For more information about Cassava Sciences,
please visit: https://www.CassavaSciences.com
For More Information Please
Contact:Kirsten Thomas, Sr. Vice-PresidentThe Ruth
Groupkthomas@TheRuthGroup.com (508) 280-6592
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 clinical studies with
PTI-125; the timing of announcing clinical results of our Phase 2b
study; the interpretation of results of clinical studies, potential
health benefits, if any, of changes in levels of biomarkers; verbal
commentaries made by Cassava Sciences’ employees; and potential
benefits, if any, of the Company’s product candidates for
Alzheimer’s disease are all 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 international outbreak of an infectious
disease, 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. The content of this press release is solely the
responsibility of the Company and does not necessarily represent
the official views of the National Institutes of Health. 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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