Cassava Sciences Initiates Phase 2b Clinical Study in Alzheimer’s Patients
September 16 2019 - 8:30AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biopharmaceutical company focused on neuroscience, today reported
initiation of a Phase 2b study of its lead drug candidate, PTI-125,
in Alzheimer’s patients. PTI-125 is a small molecule that targets
the massive neuroinflammation and neurodegeneration observed in the
Alzheimer’s brain. In conjunction with the initiation of this Phase
2b study, Cassava Sciences also reported dosing of the first two
patients for this study, both of which were uneventful. This
Phase 2b study is supported by a research grant award from the
National Institutes of Health (NIH).
“There is a profound and timely need to develop
new drug therapies for this devastating disease,” said Remi
Barbier, President & CEO. “We are pleased to advance PTI-125
into this randomized, placebo-controlled study in approximately 60
Alzheimer’s patients, and are eager to report how results of this
study will expand upon the clinical data set for PTI-125.”
Initiation of the Phase 2b study follows the
positive results reported from a Phase 2a study, demonstrating 100%
responder rate and statistically significant decreases in key
biomarkers of Alzheimer’s pathology, neuroinflammation and
neurodegeneration.
Phase 2b Study DesignThis Phase
2b clinical study is designed to evaluate safety, tolerability and
drug effects of PTI-125 on validated biomarkers of Alzheimer’s
disease. This is a blinded, randomized, placebo-controlled,
multi-center, multi-dose research study in approximately 60
patients with mild-to-moderate Alzheimer’s disease. Patients
will be dosed with PTI-125 100 mg, 50 mg, or matching placebo,
twice daily for 28 continuous days. The primary endpoint is
improvement in biomarkers of Alzheimer’s disease from baseline to
Day 28. Patient enrollment may take up to 12 months.
About PTI-125 and Cassava’s Scientific
ApproachThe target of PTI-125 is an altered form of
filamin A (FLNA), a scaffolding protein. Published studies
have shown that altered FLNA in the brain disrupts the normal
function of neurons, leading to Alzheimer’s pathology,
neurodegeneration and neuroinflammation. Cassava Sciences’ lead
drug candidate, PTI-125, is a small molecule that restores the
normal shape and function of FLNA in the brain. This action
improves the function of certain receptors in the brain and exerts
powerful anti-neuroinflammatory effects.
Cassava Sciences is also developing an
investigational diagnostic to detect Alzheimer’s disease with a
simple blood test. This program, called PTI-125Dx, also
receives significant scientific and financial support from NIH.
The underlying science for Cassava Sciences’
programs in neurodegeneration is published in several prestigious
peer-reviewed technical journals, including Journal of
Neuroscience, Neurobiology of Aging, and Journal of Biological
Chemistry. As previously announced, in 2018 the National
Institute on Aging (NIA) of the NIH awarded Cassava two research
grants following an in-depth, confidential review of its science
and technology. These two NIH grants represent up to $6.7 million
of non-dilutive financing.
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 will develop
Alzheimer’s in 2019.1 The number of people living with
Alzheimer’s disease is expected to grow dramatically in the years
ahead, which may also result in a growing social and economic
burden.2
About Cassava Sciences,
Inc.The mission of Cassava Sciences is to detect and treat
neurodegenerative diseases, such as Alzheimer’s disease. Over
the past ten 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 technology, without royalty
obligations to any third-party.
For More Information Contact: |
For Media Inquiries Contact: |
Eric Schoen, Chief Financial Officer |
Kirsten Thomas, SVP |
Cassava Sciences, Inc. |
The Ruth Group |
eschoen@CassavaSciences.com |
kthomas@TheRuthGroup.com |
(512) 501-2450 |
(508) 280-6592 |
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 disclaims any
intent or obligation to update these forward-looking statements and
claims the protection of the Safe Harbor for forward-looking
statements contained in the Act. Examples of such statements
include, but are not limited to, statements regarding the timing of
initiation or completion of Phase 2 clinical studies; the
interpretation of clinical results; and potential benefits, if any,
of the Company’s drug programs in neurodegeneration, including
Alzheimer’s disease. The Company cautions that forward-looking
statements are inherently uncertain. Such statements are based on
management's current expectations, but actual results may differ
materially due to various factors. Such statements involve risks
and uncertainties, including, but not limited to, those risks and
uncertainties relating to the ability to demonstrate the
specificity, safety, efficacy or potential health benefits of our
product candidates and including those described in the section
entitled “Risk Factors” in Cassava’s Annual Report on Form 10-K for
the year ended December 31, 2018. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date
hereof. 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 U.S.
Securities and Exchange Commission (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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