Cortexyme Provides New GAIN Trial Data at AD/PD 2022 Demonstrating Potential Benefit of Lysine Gingipain Inhibition in Mild to Moderate Alzheimer’s Population
March 21 2022 - 07:00AM
Business Wire
Target engagement and biomarker data expands
understanding of the role of P. gingivalis and the potential
benefit of lysine gingipain inhibition
Biomarker data and correlations to clinical
outcomes consistent with the gingipain hypothesis
Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage
biopharmaceutical company pioneering upstream therapeutic
approaches to improve the lives of patients diagnosed with
degenerative diseases, presented new target engagement and
biomarker data from the GAIN Trial at the AD/PD™ 2022 International
Conference on Alzheimer’s and Parkinson’s Diseases.
“Our understanding of the impact of lysine gingipain inhibition
on neurodegeneration and other Alzheimer’s disease markers
continues to expand. The evidence demonstrates our target – P.
gingivalis – may play a key upstream role in both of these areas,
and correlations between P. gingivalis biomarkers and clinical
assessments show that our ability to inhibit this target
potentially leads to improved patient outcomes,” said Michael
Detke, MD, PhD, Cortexyme’s chief medical officer. “These
additional data from the GAIN Trial provide critical insights to
help us advance our gingipain inhibitor pipeline, expanding upon
and supporting clinical evidence of this target and atuzaginstat’s
mechanism of action, in addition to helping us better identify
which patients are most likely to benefit.”
New GAIN Trial Data Highlights from AD/PD 2022
In its presentation titled “Data from the Phase 2/3 GAIN Trial
of COR388 (Atuzaginstat) for the Treatment of Mild to Moderate
Alzheimer’s Disease,” Cortexyme shared new target engagement and
biomarker data, including correlations between biomarkers and
clinical outcomes, detailed below. This presentation is the first
of multiple presentations this year which are expected to include
incremental analysis and biomarker data from the GAIN Trial.
- Target Engagement Supportive of Mechanism of Action:
GAIN Trial findings support that atuzaginstat engaged the target,
inhibiting lysine gingipains, which are essential to the survival
of P. gingivalis. Lysine gingipain inhibition by atuzaginstat
resulted in a 30% to 50% slowing of cognitive decline in the
participants with high P. gingivalis load.
- Trends to Benefit on Traditional CSF Biomarker Measures:
GAIN Trial data included the measurement of traditional Alzheimer’s
disease biomarkers, including cerebral spinal fluid (CSF)
biomarkers phospho-tau 181 and total tau. By engaging a novel
upstream target, atuzaginstat demonstrated numerical trends to
benefit in tau biomarkers, which is consistent with the observed
slowing of Alzheimer’s disease progression. These beneficial trends
were also present in the P. gingivalis DNA status (PG-DS)
prespecified subgroup, which are the most likely responders,
consistent with the gingipain hypothesis and atuzaginstat’s
efficacy.
- Trends to Benefit on Novel Brain Volumetric Biomarker
Measures: The GAIN Trial also included exploratory MRI brain
volumetric measures as biomarkers of disease modification in
Alzheimer’s disease, including bilateral hippocampal volume,
cortical thickness, and whole brain volume. All three brain
volumetric measures demonstrated consistent numerical trends with
lower rates of decline on atuzaginstat, particularly in the PG-DS
prespecified subgroup. Importantly, these brain volumetric measures
also showed correlation with the clinical co-primary endpoints
ADAS-Cog11 and ADCS-ADL. These findings further support a role of
P. gingivalis in disease progression.
To access Cortexyme’s AD/PD 2022 presentation, please visit the
Science or Investors sections of the company’s website at
www.cortexyme.com.
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
degenerative diseases, including Alzheimer’s disease,
periodontitis, and oral potentially malignant disorders, among
others. Cortexyme’s innovative approach targets a specific,
infectious pathogen called P. gingivalis found in the brain of
Alzheimer’s patients 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 “supportive,”
“benefit,” “outcomes,” “potential,” “correlations,” “efficacy” or
other similar words. Examples of forward-looking statements
include, among others, the strategic development path for
atuzaginstat; its business plans, internal and external development
of the pipeline, strategy, planned FDA submissions and clinical
trials and timeline, prospects, and milestone expectations; the
timing and success of the company’s clinical trials and related
data, including plans and the ability to initiate, conduct and/or
complete current and additional studies; 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, further development of atuzaginstat and other
programs or indications, regulatory submissions and interactions
with regulators, and related response and decisions, 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, 2022, its Quarterly Report on Form 10-Q filed with the SEC
on October 29, 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/20220321005357/en/
Stacy Roughan Cortexyme, Inc. Vice President, Corporate
Communications & Investor Relations ir@cortexyme.com
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