Cortexyme Provides Regulatory Update for COR388 Development Program in Alzheimer’s Disease
February 13 2020 - 8:00AM
Business Wire
- Interim analysis in the Phase 2/3 GAIN Trial
expected to occur in Q4 2020
Cortexyme, Inc. (Nasdaq: CRTX) today provided an update on its
clinical development plans for COR388, the company’s lead
investigational medicine in development for mild to moderate
Alzheimer’s disease (AD). The company conducted a Type C meeting
with the FDA gathering agreement and feedback on development plans
through NDA, including the Phase 2/3 GAIN Trial statistical
analysis plan, metabolite characterization, nonclinical studies,
population pharmacokinetics, and drug-drug interaction studies.
Following discussion with the FDA, the company intends to
conduct an interim analysis for overwhelming efficacy in the
ongoing GAIN Trial. The analysis, currently planned before year-end
2020, will be conducted after approximately 100 patients in each of
the GAIN Trial’s three arms complete six months of treatment. The
co-primary endpoints for the interim analysis will be change from
baseline in ADAS-Cog11 and CDR-SB versus placebo.
“Cortexyme is pleased with the collaborative and productive
dialogue with the FDA’s Division of Neurology Products,” said
Michael Detke, M.D., Ph.D., Cortexyme’s Chief Medical Officer.
“With COR388, we are pursuing a differentiated mechanism of action
that targets the gingipains, or toxic proteases, released by the
bacterium P. gingivalis, which we believe infects the brain and
causes Alzheimer’s pathology. The body of preclinical and clinical
evidence generated to date suggests COR388 could have a favorable
impact on inflammation, neurodegeneration, bacterial load of P.
gingivalis, and cognitive testing.”
Cortexyme continues to expect the GAIN Trial’s final analysis in
the fourth quarter of 2021. The co-primary endpoints will be change
from baseline in ADAS-Cog11 and CDR-SB versus placebo. The GAIN
Trial is 90% powered to meet statistical significance on both
primary endpoints with the planned 570 randomized patients.
Additional exploratory endpoints include other cognitive,
functional and clinical outcomes, safety and tolerability measures,
and biomarkers relating to P. gingivalis infection, as well as
traditional AD biomarkers and brain volume measurements. The study
is stratified for both AD severity (mild versus moderate) and ApoE4
carriers versus non-carriers.
For more information about the GAIN Trial, visit
www.GAINtrial.com.
About the GAIN Trial
The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s
Disease) Trial is a randomized, double-blind, placebo-controlled
Phase 2/3 trial evaluating the efficacy, safety, and tolerability
of COR388, Cortexyme’s investigational gingipain inhibitor, in
patients with mild to moderate Alzheimer’s disease. The GAIN Trial
also includes a sub-study measuring the efficacy of COR388 on
symptoms of periodontal disease. The GAIN Trial has been enrolling
since the second quarter of 2019, with top-line results from the
study’s final analysis expected in the fourth quarter of 2021. For
more information on the trial, visit www.gaintrial.com.
About Cortexyme
Cortexyme (Nasdaq: CRTX) is a clinical stage biopharmaceutical
company pioneering a novel, disease-modifying therapeutic approach
to treat what it believes to be a key underlying cause of
Alzheimer’s disease and other degenerative diseases. Cortexyme is
targeting a specific, infectious pathogen found in the brain of
Alzheimer’s patients and tied to neurodegeneration and
neuroinflammation in animal models. The company’s lead
investigational medicine, COR388, is the subject of the GAIN Trial,
an ongoing Phase 2/3 clinical study in patients with mild to
moderate Alzheimer’s. To learn more about Cortexyme, visit
www.cortexyme.com or follow @Cortexyme on Twitter.
Forward-Looking Statements
Statements in this press release contain “forward-looking
statements” that are subject to substantial risks and
uncertainties. Forward-looking statements contained in this press
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.
Forward-looking statements are based on Cortexyme’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict. 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
the final prospectus related to Cortexyme’s initial public offering
filed with the Securities and Exchange Commission on May 9, 2019
and Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on November 12, 2019. Forward-looking
statements contained in this press 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/20200213005432/en/
Hal Mackins For Cortexyme, Inc. hal@torchcomllc.com (415)
994-0040
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