Cortexyme’s Approach to Addressing a Key Underlying Cause of Alzheimer’s Detailed at Alzheimer’s Association Internatio...
17 Julho 2019 - 12:00PM
Business Wire
-- Rationale and design of the GAIN trial
discussed in AAIC news briefing earlier this morning
-- In Phase 1b testing, COR388 was associated
with reductions in markers of inflammation and pathological ApoE
fragmentation
Cortexyme, Inc. (Nasdaq: CRTX) today announced the presentation
of clinical data that supports its ongoing work to pioneer a novel,
disease-modifying therapeutic approach to treating a key underlying
cause of Alzheimer’s and other degenerative diseases. In a poster
presentation at the Alzheimer’s Association International
Conference® 2019 (AAIC®), researchers highlighted the Phase 1b
clinical development experience of COR388, the company’s lead
investigational gingipain inhibitor, and provided an overview of
the design for the GAIN trial, the company’s large, international
Phase 2/3 trial in patients with mild to moderate Alzheimer’s
disease (AD). AAIC is the largest international meeting dedicated
to advancing dementia science and is being held this week in Los
Angeles.
“In Phase 1a/b testing, COR388 was well tolerated and associated
with encouraging signs of early clinical activity, providing a
solid rationale for the GAIN trial, our ongoing Phase 2/3 study
that seeks to enroll approximately 570 patients with mild to
moderate Alzheimer’s disease,” said Michael Detke, M.D., Ph.D.,
Cortexyme’s chief medical officer. “The response from the
Alzheimer’s investigator and patient communities has been strong,
and we look forward to enrolling the study and fully evaluating
COR388’s utility as a potential treatment for Alzheimer’s.”
GAIN Trial’s Scientific Foundation and Clinical Trial Design
Detailed
In a Developing Topics poster (P4-663), researchers detailed the
rationale for and design of the GAIN trial, which began enrolling
subjects in the United States in April 2019. The trial represents
the first large, randomized late-stage clinical study evaluating
the gingipain hypothesis, which is based upon growing evidence that
the bacterium most commonly associated with chronic periodontal
disease, Porphyromonas gingivalis, plays a key role in the
development of AD, given its identification in the brains of AD
patients and ability to cause neurodegeneration, inflammation, and
other pathology associated with Alzheimer’s in animal models. In
these models, the pathological effects were blocked by COR388,
which targets the gingipains, or toxic proteases, released by P.
gingivalis as it colonizes tissue.
The GAIN trial is based on Phase 1b data demonstrating benefits
on both biomarkers and cognitive endpoints. After a 10-day multiple
ascending dose study in 24 older healthy volunteers showed an
encouraging tolerability and safety profile, a 28-day study of nine
subjects with mild to moderate AD between the ages of 55 and 85 was
conducted. Participants showed a trend to improvement on several
measures of cognition, including the Mini-Mental State Exam (MMSE)
and Cambridge Neuropsychological Test Automated Battery (CANTAB)
memory composite of cognitive function score, measures commonly
used to assess cognitive impairment in Alzheimer’s patients.
Researchers also reported a statistically significant improvement
for COR388 versus placebo on multiple measures of the Winterlight
Cognitive Assessment, a new speech-based testing platform intended
to identify cognitive impairment associated with dementia. Across
the Phase 1b study, as well as single and multiple ascending dose
studies in healthy volunteers, COR388 twice daily was found to be
well tolerated and brain penetrant.
As part of an AAIC news briefing earlier this morning, lead
author Michael Detke, M.D., Ph.D. shared data from the patient
cohort demonstrating a reduction in markers of inflammation in the
blood (plasma RANTES), as well as a reduction in pathological ApoE
fragments in the cerebrospinal fluid (CSF), which suggests another
potential benefit of inhibiting gingipain activity in the brains of
patients.
“COR388 has been shown to block ApoE fragmentation in in vitro,
and, as seen at AAIC today, human studies,” said Michael Detke. “We
believe this makes COR388 the first investigational small molecule
to show beneficial effects related to pathological fragmentation of
ApoE, the most common genetic risk factor for Alzheimer’s. More
research is needed, but the data generated to date suggests another
avenue by which Porphyromonas gingivalis is implicated in
Alzheimer’s pathogenesis.”
Spurred by the totality of data from Phase 1a/b testing,
investigators are now enrolling subjects in the GAIN trial, which
is targeting an enrollment of up to 570 patients with mild to
moderate AD at ~90 sites in the United States and Europe.
Participants are randomized to one of two doses of COR388 capsules
(40mg or 80mg twice daily) or placebo. The primary endpoint of the
study is the mean change in the Alzheimer’s disease Assessment
Scale-Cognitive Subscale 11 (ADAS-Cog11), a measure that has
supported past regulatory approval of drugs to treat Alzheimer’s
disease, along with secondary endpoints of function ADCS-ADL and
CDR-SB. Cortexyme has developed a sensitive assay for Porphyromonas
gingivalis DNA in the central nervous system, and biomarkers of the
infection in the saliva, blood and CSF are being closely tracked
for responder analyses. Top-line results from the GAIN trial are
expected by the end of 2021.
About Cortexyme, Inc.
Cortexyme (Nasdaq: CRTX) is a clinical stage biopharmaceutical
company pioneering a novel disease-modifying therapeutic approach
to treat 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 disease. More information about
the trial can be found at www.GAINtrial.com. To learn more about
Cortexyme, visit www.cortexyme.com.
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 June 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/20190717005513/en/
Hal Mackins For Cortexyme, Inc. hal@torchcomllc.com (415)
994-0040
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