Top-line Results from a Phase 2b Study of PTI-125 in Alzheimer’s Disease Does Not Meet Primary Endpoint
May 15 2020 - 8:15AM
Cassava Sciences, Inc. (Nasdaq: SAVA) today reported top-line
results from a Phase 2b study of PTI-125, its lead investigational
drug, in patients with Alzheimer’s disease. This study did not meet
its primary endpoint. The pre-specified primary endpoint was a
statistically significant effect of PTI-125 versus placebo on
cerebrospinal fluid (CSF) levels of tau protein and other biomarker
assessments from baseline to Day 28. PTI-125 significantly reduced
a secondary endpoint, CSF levels of IL1-beta (p<0.035), a core
biomarker of neuroinflammation, from baseline to Day 28. Drug
was safe and well-tolerated.
A post-hoc analysis of biomarker data revealed
high variability in levels of CSF biomarkers over 28 days. For
example, placebo-treated patients recorded changes in levels of CSF
tau and p-tau ranging from -54% to +34% and -49% to +253%,
respectively, from baseline to Day 28. Biomarker analysis was
conducted by outside labs.
The drug effects of PTI-125, if any, may have
been masked in this study by high variability in levels of
biomarkers of disease. In the months ahead the Company plans to
re-analyze CSF biomarkers from all study participants.
“Today’s top-line results disappoint and are not
consistent with previous clinical experience for reasons that are
unclear at the moment,” said Remi Barbier, President & CEO. “We
plan to thoroughly analyze these top-line data, and to re-analyze
CSF biomarkers from study participants, to better understand the
outcome of this study. Alzheimer’s is a disease in dire need of new
treatments. It is worth reflecting on what we can learn from this
study and how to move forward with drug development plans for
PTI-125 in Alzheimer’s disease.”
Phase 2b Study DesignPhase 2b
was a double-blind, randomized, placebo-controlled study of PTI-125
in 64 patients with mild-to-moderate Alzheimer’s disease, 50-85
years of age, with MMSE 16 to 26. Participants received PTI-125 100
mg, 50 mg or matching placebo, twice-daily, for 28 continuous
days.
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 Cassava Sciences,
Inc.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, please visit:
https://www.CassavaSciences.com
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 interpretation of results of
clinical studies, potential health benefits, if any, of changes in
levels of biomarkers; variability in levels of biomarkers of
disease; plans to have CSF samples from all Phase 2b study
participants re-analyzed; 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 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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