In overall population, co-primary endpoints of
ADAS-Cog11 and ADCS-ADL were not met
Pre-specified subgroups representing up to half
of the participants based on P. gingivalis infection level showed
approximately 50% slowing of cognitive decline
Clinical data validated upstream mechanism of
action and benefits of targeting P. gingivalis
Additional top-line GAIN Trial results to be
presented at CTAD 2021 on November 11th
Cortexyme to host investor conference call
today Tuesday, October 26th at 4:30 p.m. Eastern Time
Cortexyme, Inc. (Nasdaq: CRTX) today reported top-line results
from its Phase 2/3 GAIN Trial, a double-blind, placebo-controlled
study evaluating the efficacy of atuzaginstat (COR388), an
investigational orally administered small-molecule that targets
gingipain proteases from the bacterium Porphyromonas gingivalis (P.
gingivalis). The 643-participant study in mild to moderate patients
with Alzheimer’s disease did not meet statistical significance in
its co-primary cognitive and functional endpoints as measured by
ADAS-Cog11 and ADCS-ADL at end of the treatment period in the
overall cohort.
The pre-specified subgroup of participants with P. gingivalis
DNA detectable in saliva at baseline (PG-DS; n=242) showed a dose
response, with a 57% slowing of cognitive decline as measured by
ADAS-Cog11 in the 80 mg BID arm (p=0.02) and a 42% slowing in the
40 mg BID arm (p=0.07) vs. placebo. Significant benefits in this
subgroup were not seen on the other co-primary, ADCS-ADL. The
cognitive benefit of atuzaginstat in patients with high P.
gingivalis infection was reinforced by similar results in multiple
pre-specified infection related subgroups and with multiple methods
of analysis. Additionally, reductions in P. gingivalis in saliva at
week 24 were significantly correlated with improved outcomes at the
end of the treatment period as measured by ADAS-Cog11 (p=0.0007),
Clinical Dementia Rating–Sum of Boxes (CDR) (p=0.004), Mini-Mental
State Exam (MMSE) (p=0.007), and a beneficial trend on ADCS-ADL
(p=0.08).
The sub-study in periodontal disease demonstrated a trend to
benefit on the primary clinical endpoint of pocket depth in the
same pre-specified sub-group with P. gingivalis DNA detectable in
saliva. Further results will inform the next stage of development
in periodontitis and will be presented at a future scientific
conference.
“Today marks a major milestone toward a comprehensive
understanding of Alzheimer’s and slowing of disease progression.
The evidence from the GAIN Trial advances our ability to identify
the right patients, impact an upstream target, and improve patient
outcomes,” said Casey Lynch, Cortexyme’s chief executive officer,
co-founder, and chair. “We are focused on next steps to advance
this breakthrough treatment for the benefit of patients and their
families.”
Most adverse events were mild to moderate in severity. The most
common were gastrointestinal, such as diarrhea in up to 16% and
nausea in 6% of participants treated with atuzaginstat vs. 3% and
2% of placebo participants, respectively. Atuzaginstat was
associated with dose-related liver enzyme elevations >3X the
upper limit of normal: 2% on placebo, 7% on 40 mg BID, and 15% on
80 mg BID. These elevations alone were not clinically significant,
and virtually all participants were asymptomatic. Two participants
in the 80 mg BID arm had concomitant bilirubin elevations without
alternative explanation. Lab changes resolved while participants
remained on drug or after withdrawal without any known long-term
adverse effects. Atuzaginstat treated groups showed no increase in
ARIA (amyloid-related imaging abnormalities), including
microhemorrhage and edema, or superficial siderosis.
“The first large clinical study of a gingipain inhibitor
confirmed the benefits of treatment in the appropriate population
at doses that reduce P. gingivalis. Disease modification and
preservation of cognition as demonstrated in the GAIN Trial
provides the foundation for altering the course of Alzheimer’s,”
said Michael Detke, MD, PhD, Cortexyme’s chief medical officer.
“The P. gingivalis-infected participant population was easily
identified with saliva or simple blood tests and was highly
responsive to atuzaginstat treatment on multiple clinical measures,
and we will be discussing next steps with global regulators
promptly. We are grateful to the participants, caregivers, and
investigators for their participation and dedication to this
important study.”
In light of the GAIN Trial results and the significant unmet
medical need in Alzheimer’s, Cortexyme is actively engaging with
regulators, the medical community, patient advocacy groups, and
other key stakeholders to advance development of atuzaginstat and
the second-generation lysine-gingipain inhibitor COR588, which is
differentiated by novel compound properties and once daily
administration.
Additional Top-line GAIN Trial Results at CTAD 2021 on
November 11th
Cortexyme will present the additional top-line results from the
GAIN Trial at the upcoming 14th Clinical Trials on Alzheimer's
Disease (CTAD 2021) conference on Thursday, November 11, 2021, at
11:35 a.m. Eastern Time in Boston, Massachusetts. Access to
Cortexyme’s CTAD 2021 presentation will be available on the
company’s Investor Relations website at ir.cortexyme.com.
Investor Call Today at 4:30 p.m. Eastern Time
Cortexyme management will discuss the GAIN Trial top-line
results during an investor conference call beginning at 4:30 p.m.
Eastern Time today, Tuesday, October 26, 2021. To join the call,
participants may dial 877-451-6152 (domestic) or 201-389-0879
(international) and provide the conference ID: 13724711. To listen
to a live webcast of the conference call, visit the Investor
Calendar page under the News & Events heading of the
Cortexyme’s Investor Relations website at ir.cortexyme.com. A
replay of the conference call will be made available and accessible
on Cortexyme’s Investor Relations website shortly after the live
call concludes.
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. Cortexyme’s lead
program 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 “anticipate,”
“expect,” “believe,” “will,” “may,” “should,” “estimate,”
“project,” “outlook,” “forecast,” “potential” or other similar
words. Examples of forward-looking statements include, among
others, plans to present additional data from the GAIN Trial at
CTAD 2021 and other medical meetings, the strategic development
path for atuzaginstat, its business plans, strategy, planned
clinical trials and timeline, prospects, and milestone
expectations; the timing and success of the company’s clinical
trials and related data, including with respect to the GAIN Trial,
as well as enabling and human studies of COR588; 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, further
development of atuzaginstat and COR588, regulatory submissions and
related response and decisions, including with respect to the
company’s partial clinical hold, 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 August 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211026006180/en/
Cortexyme Contact: Stacy Roughan Cortexyme, Inc. Vice
President, Corporate Communications & Investor Relations
ir@cortexyme.com
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