Cortexyme Announces GAIN Trial of Atuzaginstat in Alzheimer’s Disease Has Reached Enrollment Milestone of 500 Patients
14 August 2020 - 10:00PM
Business Wire
- Open label extension is currently active for
GAIN Trial completers in the United States with robust conversion
of eligible patients
- Interim analysis of the Phase 2/3 GAIN Trial
expected to occur before year-end 2020
Cortexyme, Inc. (Nasdaq: CRTX) today announced that enrollment
in its GAIN Trial for Alzheimer’s disease (AD) has reached 500
patients toward the study’s previously announced enrollment target
of 570 subjects. GAIN is a randomized, double-blind,
placebo-controlled Phase 2/3 trial of atuzaginstat (COR388),
Cortexyme’s lead investigational medicine, in patients with mild to
moderate AD. The GAIN Trial’s protocol includes an interim analysis
on the study’s co-primary cognitive and functional endpoints after
approximately 300 patients reach 24 weeks of treatment; this
interim analysis is expected to occur before year-end 2020.
Top-line results of the GAIN Trial’s final analysis, to be
performed once all study subjects complete the one-year study, are
expected in Q4 2021.
Atuzaginstat targets the toxic proteases, or gingipains,
produced by P. gingivalis, which have been discovered in greater
than 90% of post-mortem brains of patients with AD and shown to
produce Alzheimer’s pathology in infected animals. P. gingivalis is
best known as a keystone bacterium in the development of
periodontal disease. The GAIN Trial includes a periodontal
sub-study, in which approximately 40% of GAIN Trial participants
are also assessed for endpoints of efficacy in periodontal disease.
Of the sub-study participants enrolled to date, greater than 90%
had moderate to severe periodontal disease at baseline.
“We are gratified to see the continued high level of engagement
of our clinical sites and study participants and their caregivers,
especially during the last several months,” said Michael Detke,
M.D., Ph.D., Cortexyme’s chief medical officer. “The fact that GAIN
Trial timelines have not been impacted by the COVID-19 pandemic
reflects the devastating impact of Alzheimer’s disease, the
significant need for new therapeutic options for patients, and the
growing interest in atuzaginstat’s mechanism of action, which is
‘upstream’ of other approaches. We expect to complete GAIN
enrollment in the next few months and look forward to sharing study
results when available.”
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 atuzaginstat (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 including gingival pocket
depth. 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, 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. Based upon the
evidence generated to date, Cortexyme is currently advancing its
lead therapeutic candidate, atuzaginstat (COR388), in the GAIN
Trial, an ongoing Phase 2/3 clinical trial in patients with mild to
moderate Alzheimer’s disease. Cortexyme is targeting a specific,
infectious pathogen found in the brain of Alzheimer’s patients and
tied to neurodegeneration and neuroinflammation in animal models.
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. Examples
of forward-looking statements include, among others, statements we
make regarding our business plans and prospects, the timing and
success of our clinical trials and related data, the potential of
atuzaginstat to treat Alzheimer’s disease , our ability to fund
planned operating and capital expenditures, the timing of
announcements and updates relating to our clinical trials and
related data, the timing of and our ability to enroll patients into
our clinical trials, and the potential therapeutic benefits, safety
and efficacy of our product candidate or library of compounds.
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 we expect. 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
our Annual Report on Form 10-K filed with the Securities and
Exchange Commission (SEC) on March 16, 2020, our Quarterly Report
on Form 10-Q filed with the SEC on May 12, 2020, and other reports
as filed with the SEC. 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/20200814005238/en/
Media Contact: Hal Mackins For Cortexyme, Inc.
hal@torchcomllc.com (415) 994-0040
Investor Contact: Chris Lowe Chief Financial Officer
Cortexyme, Inc. clowe@cortexyme.com
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