New GAIN Trial baseline data demonstrates
majority of patients have elevated Von Willebrand factor and
alpha-2-macroglobulin
Cortexyme to host AAIC symposium titled
“Getting to the Root Cause of Alzheimer’s Disease: An Innovative,
Upstream Approach for Disease Modification” on Tuesday, July 27
Join KOL webinar on atuzaginstat titled
“Innovation in Alzheimer's Disease – Getting to the Root Cause of
Neurodegeneration” on Friday, July 30 at 10 a.m. ET
Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal
trial in Alzheimer’s disease with top-line data expected in the
fourth quarter of 2021 and a growing pipeline of therapeutics for
degenerative diseases, announced the presentation of new
preclinical data linking P. gingivalis to increased levels of
phospho-tau217, an emerging biomarker for Alzheimer’s disease. This
research, along with new baseline data from its pivotal GAIN Trial,
is being presented by the company at the Alzheimer's Association
International Conference® 2021 (AAIC®) taking place July 26-30,
2021, in Denver, Colorado, as well as virtually. In addition to its
presentations, Cortexyme will host a corporate sponsored symposium
held in conjunction with the conference titled “Getting to the Root
Cause of Alzheimer’s Disease: An Innovative, Upstream Approach for
Disease Modification” on Tuesday, July 27, 2021, from 5:30 p.m. to
7:30 p.m. MT.
“Cortexyme continues to conduct research that validates and
reinforces the gingipain hypothesis and P. gingivalis’ role as a
causative agent of Alzheimer’s disease,” said Casey Lynch,
Cortexyme’s chief executive officer, co-founder, and chair. “The
GAIN Trial, which is designed to be 90% powered to show a 50%
slowing of disease, will read out on the gold standard measures of
disease modification as Cortexyme looks to shift the paradigm in
effective Alzheimer’s treatment.”
Cortexyme is pioneering an innovative, upstream, and
disease-modifying therapeutic approach to Alzheimer's disease. The
Phase 2/3 GAIN Trial is a potentially pivotal study in 643 patients
with mild to moderate Alzheimer’s Disease. Cortexyme’s seminal
discovery, along with confirmatory clinical and preclinical
studies, demonstrate that the intracellular pathogen, P.
gingivalis, is found in the brain of more than 90% of Alzheimer’s
patients and that a simple oral infection with P. gingivalis in
animals results in brain infiltration and downstream hallmark
Alzheimer’s pathologies, including Aβ42 production, tau
hyperphosphorylation, microglial activation, and neurodegeneration.
The company’s lead drug candidate, atuzaginstat (COR388), is a
first-in-class, orally administered, brain penetrant small molecule
targeting P. gingivalis, which is upstream of neuronal death and
Alzheimer’s disease pathology. Atuzaginstat blocks gingipains,
protease virulence factors secreted by P. gingivalis, which are
required for its survival and responsible for its toxicity. The
GAIN Trial also includes a REPAIR sub-study of 233 patients
targeting P. gingivalis – most commonly known as a keystone
bacterium associated with periodontal disease – and measuring the
efficacy of atuzaginstat on clinical endpoints of periodontal
disease. Cortexyme’s innovative therapeutic approach continues to
be supported by research from laboratories around the world
published in peer-reviewed scientific journals.
Cortexyme’s work will be featured in two poster presentations at
AAIC 2021:
- Increased Levels of Phospho-tau217 Linked to P. gingivalis
Reduced by Atuzaginstat: In its poster “Increased levels of
phospho-tau217 in neuron cultures and CVN mice infected with
Porphyromonas gingivalis” (Poster #52438), Cortexyme demonstrates
P. gingivalis infected neuronal cell cultures and chronically
infected CVN mice display elevated tau phosphorylation at T217
(phospho-tau217). Using IPSC-derived neuron cultures,
neuron-astrocyte-microglia co-cultures, and CVN mice (APPSwDI/NOS2
bigenic) as model systems for P. gingivalis-induced Alzheimer’s
disease, the company demonstrated that phospho-tau217 was
susceptible to P. gingivalis-induced and gingipain dependent
digestion in a dose-dependent manner. At lower infection levels,
tau protein persisted and an elevated phospho-tau217/total tau
ratio was observed in a manner that might reflect the physiological
level of gingipain exposure. In CVN mice chronically infected with
P. gingivalis, the phospho-tau217/total tau ratio was elevated in
the brain in infected compared to uninfected mice. Furthermore,
after five weeks of treatment with atuzaginstat, the level of
phospho-tau217 was similar to that seen in uninfected controls,
while tau degradation was completely inhibited by treatment with
atuzaginstat.
- New Baseline Data from GAIN Trial: In its poster titled
“An update and baseline data from the Phase 2/3 GAIN trial of
COR388 (atuzaginstat) a novel bacterial virulence factor inhibitor
for the treatment of Alzheimer’s Disease” (Poster #50624),
Cortexyme shares updated and new baseline biomarker data from the
full set of patients in the study that supports that this is an
appropriate population for testing atuzaginstat for Alzheimer’s
disease. In addition to demonstrating that 100% of patients have
evidence of systemic P. gingivalis exposure, GAIN baseline
biomarker highlights include traditional CSF biomarkers Aβ, total
tau, and phospho-tau 181. New data shows that a majority of
patients have elevated Von Willebrand factor (vWF), a vascular
injury marker, and alpha-2-macroglobulin (A2M), an endogenous
protease inhibitor, in serum. GAIN baseline demographics also
demonstrate that 90% of its periodontal disease REPAIR sub-study
patients have moderate to severe periodontitis without requiring it
as a criterion for study participation.
Cortexyme AAIC Symposium – Getting to the Root Cause of
Alzheimer’s Disease
Cortexyme will host a corporate sponsored symposium and dinner
held in conjunction with AAIC 2021 titled “Getting to the Root
Cause of Alzheimer’s Disease: An Innovative, Upstream Approach for
Disease Modification” on Tuesday, July 27, 2021, from 5:30 p.m. to
7:30 p.m. MT at the Hilton Denver City Center. Led by Cortexyme’s
chief executive officer and co-founder Casey Lynch and chief
medical officer Michael Detke, M.D., Ph.D., the symposium will
provide an informative presentation on how Cortexyme is moving
beyond the prevailing targets to deliver a game-changing shift in
Alzheimer’s disease treatment. For AAIC 2021 registered
participants wishing to attend Cortexyme’s symposium in person,
please email info@cortexyme.com to sign up. The symposium also may
be accessed online by registering to attend AAIC 2021 through its
virtual conference experience here.
KOL Webinar: Innovation in Alzheimer's Disease – Getting to
the Root Cause of Neurodegeneration
In conjunction with its participation at AAIC 2021, Cortexyme is
hosting a key opinion leader (KOL) webinar titled “Innovation in
Alzheimer's Disease – Getting to the Root Cause of
Neurodegeneration” on Friday, July 30, 2021, at 10:00 a.m. ET. The
webinar will feature KOL Marwan Noel Sabbagh, M.D., (Cleveland
Clinic) who will discuss the current treatment landscape of
Alzheimer’s disease and dementia, the unmet medical need, as well
as recent activity and evidence to support the role of P.
gingivalis as an important upstream driver of Alzheimer’s disease
pathology. Dr. Sabbagh will also address new baseline data from
Cortexyme’s pivotal Phase 2/3 GAIN Trial of atuzaginstat for the
treatment of Alzheimer’s disease being presented at AAIC 2021.
Cortexyme's management team will provide an update on its ongoing
pivotal Phase 2/3 GAIN Trial, which builds on Phase 1 data
demonstrating atuzaginstat was well tolerated in both healthy
subjects and in patients with Alzheimer’s disease. Dr. Sabbagh and
Cortexyme’s management will be available to answer questions
following the formal presentations. To register for this webinar,
please click here.
Marwan Noel Sabbagh, M.D., board certified neurologist and
geriatric neurologist, hopes to work himself out of a job.
Considered one of the leading experts in Alzheimer’s and dementia,
he is the Camille and Larry Ruvo Endowed Chair for Brain Health and
Director of Translational Research at Cleveland Clinic Lou Ruvo
Center for Brain Health in Las Vegas. Dr. Sabbagh has dedicated his
career to finding a cure for Alzheimer’s and other age-related
neurodegenerative diseases. Dr. Sabbagh is a leading investigator
for many prominent national Alzheimer’s prevention and treatment
trials. Dr. Sabbagh is on the editorial board for Journal of
Alzheimer's Disease and BMC Neurology. He is now editor in chief of
Neurology and Therapy. He has authored and co-authored almost 370
medical and scientific articles on Alzheimer’s research. Dr.
Sabbagh is the author of The Alzheimer’s Answer: Reduce Your Risk
and Keep Your Brain Healthy, with foreword by Justice Sandra Day
O’Connor, and The Alzheimer’s Prevention Cookbook: 100 Recipes to
Boost Brain Health. He has edited Palliative Care for Advanced
Alzheimer’s and Dementia: Guidelines and Standards for Evidence
Based Care and Geriatric Neurology published in 2014 and Fighting
for my Life: living in the shadow of Alzheimer’s disease published
in 2019. He has been recognized with numerous awards, including
WestMarc Innovator Award, 2015; Fellow of the American Academy of
Neurology, 2004. Dr. Sabbagh earned his undergraduate degree from
the University of California, Berkeley and his medical degree from
the University of Arizona in Tucson. He received his residency
training in neurology at Baylor College of Medicine, Houston,
Texas, and completed his fellowship in geriatric neurology and
dementia at the University of California, San Diego School of
Medicine, where he served on the faculty as assistant professor.
Before joining the faculty of the Cleveland Clinic, he was at the
Barrow Neurological Institute where he served for three years, and
prior to that he was the director of the Banner Sun Health Research
Institute for 15 years.
About Cortexyme
Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage
biopharmaceutical company pioneering upstream therapeutic
approaches designed to improve the lives of patients diagnosed with
Alzheimer’s and other degenerative diseases. The company is
advancing its disease-modifying pivotal GAIN Trial in mild to
moderate Alzheimer's disease with top-line data expected in the
fourth quarter of 2021, in addition to growing a proprietary
pipeline of first-in-class small molecule therapeutics for
Parkinson’s disease, periodontitis, and other diseases with high
unmet clinical need. Cortexyme’s lead program targets a specific,
infectious pathogen called P. gingivalis found in the brain and
other organs and tied to degeneration and inflammation in humans
and animal models. The company’s causation evidence for Alzheimer’s
disease and the mechanism of its novel therapeutic has been
independently replicated and confirmed by multiple laboratories
around the world, as well as published in peer-reviewed scientific
journals. To learn more about Cortexyme, visit www.cortexyme.com or
follow @Cortexyme on Twitter.
Forward-Looking Statements
Statements in this news release contain “forward-looking
statements” that are subject to substantial risks and
uncertainties. Forward-looking statements contained in this news
release may be identified by the use of words such as “anticipate,”
“expect,” “believe,” “will,” “may,” “should,” “estimate,”
“project,” “outlook,” “forecast,” or other similar words. Examples
of forward-looking statements include, among others, statements we
make regarding our business plans, strategy, timeline, prospects,
and milestone expectations; the timing and success of the company’s
clinical trials and related data, including with respect to the
GAIN and REPAIR Trials; the potential of atuzaginstat to treat
Alzheimer’s disease, periodontal disease, and other potential
indications; the timing of announcements and updates relating to
its clinical trials and related data; the potential therapeutic
benefits, safety and efficacy of the company’s product candidate or
library of compounds and statements about its ability to obtain,
and the timing relating to, regulatory submissions and approvals
with respect to the company’s drug product candidate.
Forward-looking statements are based on Cortexyme’s current
expectations and are subject to inherent uncertainties, risks, and
assumptions that are difficult to predict and could cause actual
results to differ materially from what the company expects.
Further, certain forward-looking statements are based on
assumptions as to future events that may not prove to be accurate.
Factors that could cause actual results to differ include, but are
not limited to, the risks and uncertainties described in the
section titled “Risk Factors” in Cortexyme’s Annual Report on Form
10-K filed with the Securities and Exchange Commission (SEC) on
March 1, 2021, its Quarterly Report on Form 10-Q filed with the SEC
on May 6, 2021, and other reports as filed with the SEC.
Forward-looking statements contained in this news release are made
as of this date, and Cortexyme undertakes no duty to update such
information except as required under applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210726005203/en/
Stacy Roughan Cortexyme, Inc. Vice President, Corporate
Communications & Investor Relations ir@cortexyme.com
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