Cortexyme Presents New Data Demonstrating Evidence of P. Gingivalis Infection of the Central Nervous System in Alzheimer’s Disease at Annual Biomarkers for Alzheimer’s Disease Summit
August 25 2021 - 7:00AM
Business Wire
GAIN Trial analysis of anti-P. gingivalis
antibodies in cerebrospinal fluid supports upstream role of
pathogenic bacterium in key Alzheimer’s pathologies
Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal
trial in Alzheimer’s disease with top-line data expected by
mid-November 2021 and a growing pipeline of therapeutics for
degenerative diseases, announced the presentation of new data
demonstrating evidence of P. gingivalis infection of the central
nervous system in Alzheimer’s disease at the Annual Biomarkers for
Alzheimer’s Disease Summit taking place virtually on Wednesday,
August 25, 2021, at 2:10 p.m. ET followed by a live Q&A at 3:40
p.m. ET.
In a featured speaker presentation titled “Use of Novel
Biomarkers of P. Gingivalis Infection & Neuroinflammation in
the GAIN Trial: An Ongoing Phase 2/3 Clinical Trial Assessing the
Activity of Atuzaginstat in Patients with Mild to Moderate
Alzheimer’s Disease,” Cortexyme’s Executive Vice President of
Research and Development Leslie Holsinger, Ph.D., will present an
analysis of anti-P. gingivalis antibodies in cerebrospinal fluid
(CSF) with results demonstrating that:
- All patients analyzed at baseline in the GAIN Trial (472 out of
472 baseline CSF samples available) were positive for anti-P.
gingivalis antibodies (IgG) in their cerebrospinal fluid;
- Less than 2% of patients analyzed had a leaky blood brain
barrier, as defined by an albumin index greater than 9; and
- Anti-P. gingivalis IgG in the CSF was only very weakly
correlated to the albumin index (r=0.22), indicating production in
the central nervous system in addition to that shown previously in
serum.
These data add to the growing body of evidence indicating the
presence of a P. gingivalis infection within the central nervous
system in patients with Alzheimer’s disease. Cortexyme will also
present other novel biomarkers developed to track markers of P.
gingivalis and Alzheimer’s disease, in addition to highlighting the
upstream role that P. gingivalis plays in key pathologies of
Alzheimer’s disease progression. The complete presentation will be
available here.
About The GAIN Trial
Cortexyme is pioneering an innovative, upstream, and
disease-modifying therapeutic approach to Alzheimer's disease. The
Phase 2/3 GAIN Trial is a 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 an 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
– 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.
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 by
mid-November 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,” “potential” or other similar
words. Examples of forward-looking statements include, among
others, statements Cortexyme makes regarding the sufficiency of its
cash position to fund its operations; its 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, as well as
enabling and human studies of COR588; the potential of atuzaginstat
to treat Alzheimer’s disease, periodontal disease, and other
potential indications; the potential of COR803 to treat coronavirus
infections; 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 August 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/20210825005228/en/
Stacy Roughan Cortexyme, Inc. Vice President, Corporate
Communications & Investor Relations ir@cortexyme.com
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