Cortexyme Presents New Data Demonstrating Atuzaginstat Disrupts Biofilms & is Efficacious in Preclinical Models of Periodonta...
July 21 2021 - 7:00AM
Business Wire
Leading drug candidate penetrates and disrupts
bacterial biofilms, a key feature for efficacy in treating P.
gingivalis driven disease
Atuzaginstat reverses alveolar bone loss in
mice after oral P. gingivalis infection at doses relevant for
therapeutic efficacy in periodontal disease
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 new preclinical data
demonstrating efficacious dose range finding data for its lead drug
candidate atuzaginstat (COR388) in periodontal disease in
conjunction with its participation at the International Association
for Dental Research (IADR) 2021 General Session & Exhibition, a
virtual event. Periodontal disease represents a significant unmet
market of 65 million people in the U.S. alone.
New data presented at the IADR 2021 conference by Cortexyme
showed its lead clinical small molecule, atuzaginstat, was able to
engage and inhibit its target, lysine-gingipain from P. gingivalis,
within a biofilm and disrupt the biofilm integrity. The inability
of traditional antibiotics to penetrate oral biofilms at
therapeutic concentrations is a major reason for their lack of
efficacy in treating chronic periodontitis. The company also
confirmed that a second-generation lysine-gingipain inhibitor,
COR588, demonstrated biofilm penetration and target engagement
similar to atuzaginstat and is planned to begin Phase I studies in
the third quarter 2021. In a second presentation at IADR 2021,
Cortexyme presented data from preclinical studies demonstrating
that atuzaginstat was efficacious in reversing alveolar bone loss
induced by oral P. gingivalis infection.
“As top-line data for our GAIN Trial rapidly approaches in the
fourth quarter 2021, Cortexyme is in a unique position with a
pivotal clinical study of our lead drug candidate atuzaginstat that
targets the infectious pathogen P. gingivalis not only as the
causative agent of Alzheimer’s disease, but also its
well-established role as a keystone bacterium for periodontal
disease. This presents us with the potential to provide innovative
and breakthrough treatments in two high unmet clinical need areas
with a first-in-class, orally administered small molecule,” said
Casey Lynch, Cortexyme’s chief executive officer, co-founder and
chair. “The 233-patient periodontal disease REPAIR sub-study of the
GAIN Trial evaluates standard clinical endpoints of periodontitis,
including gingival pocket depth, clinical attachment, and bleeding
on probing. We look forward to reporting top-line data from the
REPAIR sub-study in the fourth quarter 2021.”
New data will be featured in two poster sessions at IADR
2021:
- Atuzaginstat Penetrates Biofilms for Periodontal Disease
Therapeutic Efficacy: At Cortexyme’s IADR 2021 poster session
titled “Gingipain Inhibitors Penetrate And Inhibit Gingipains In
Porphyromonas gingivalis Biofilms” (Abstract #3571509) taking place
Friday, July 23, 2021, starting at 3:45 p.m. ET, new data will be
presented demonstrating the efficacy of atuzaginstat and COR588 to
penetrate in vitro surface attached biofilms. Biofilms are one of
the primary reasons that other molecules like broad spectrum
antibiotics are ineffective against P. gingivalis. Biofilm cultures
demonstrated decreased potency of the broad-spectrum antibiotic
amoxicillin relative to planktonic growth as expected for robust
biofilms. Atuzaginstat and the company’s second generation COR588
exhibited significant time and concentration-dependent inhibition
of lysine-gingipain activity, while maintaining their target
selectivity within the biofilms to inhibit lysine-gingipain. Other
similarly potent gingipain inhibitors were less capable of activity
within the biofilm.
- Atuzaginstat Efficacious in Mouse Model of Periodontal
Disease: At Cortexyme’s IADR 2021 poster session titled “Novel
lysine-gingipain inhibitor atuzaginstat (COR388) is efficacious in
a mouse model of periodontal disease” (Abstract #1756) taking place
Friday, July 23, 2021, starting at 11:00 a.m. ET, new data will be
presented that demonstrates that atuzaginstat, a first-in-class
brain-penetrant lysine-gingipain inhibitor, was effective in
reversing alveolar bone loss in mice after repeated oral P.
gingivalis infection. Mice were orally infected with P. gingivalis
for 42 days and treated from day 35 through day 70 with oral
administration of atuzaginstat. Multiple studies were used to
determine an effective exposure and dose regimen. A previously
peer-reviewed publication established efficacy of atuzaginstat in
reducing oral infection and periodontal disease in a naturally
occurring aged dog model (Aratsu-Kapur et al. 2021).
KOL Webinar: Innovation in Periodontal Disease – A Major
Unmet Medical Need
In conjunction with its participation at IADR 2021, Cortexyme is
hosting a key opinion leader (KOL) webinar titled “Innovation in
Periodontal Disease – A Major Unmet Medical Need” on Friday, July
23, 2021, at 10:00 a.m. ET. The webinar will feature KOL Mark
Ryder, D.M.D., (University of California, San Francisco) who will
discuss the unmet medical need in treating patients with P.
gingivalis-induced periodontal disease and Cortexyme management
will present new data from the company’s IADR 2021 abstracts. An
update on the REPAIR Phase 2 periodontal sub-study of atuzaginstat
as part of its pivotal Phase 2/3 GAIN Trial in Alzheimer’s disease
will also be presented. Dr. Ryder and Cortexyme’s management will
be available to answer questions following the formal
presentations. To register for this webinar, please click here.
Mark Ryder, D.M.D., is a Professor of Periodontology and former
Chair of Periodontology and Director of the Postgraduate program in
Periodontology at the University of California, San Francisco where
he has been a faculty member for the past 41 years. He received his
dental and specialty training from the Harvard School of Dental
Medicine. He is the author of over 190 articles, abstracts, and
book chapters and has lectured extensively on a variety of research
and educational topics. He serves as an Associate Editor of the
Journal of Periodontal Research and is on the Editorial Board of
several dental research journals. He has also served as a chair
and/or reviewer on several NIH study sections and other national
and international peer review grant organizations, in addition to
serving as a consultant for several national and international
accreditation programs for dental education. His current research
interests include connections between periodontal diseases and
Alzheimer’s Disease, the links between oral and systemic health in
HIV patients, and basic research and clinical trials on novel
periodontal therapies.
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/20210721005200/en/
Stacy Roughan Cortexyme, Inc. Vice President, Corporate
Communications & Investor Relations ir@cortexyme.com
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