Cortexyme Announces the Initiation of an Open-Label Extension Study for the GAIN Trial of COR388 in Alzheimer’s Disease
January 13 2020 - 7:00AM
Business Wire
– Open-label extension study will provide
COR388 to patients for an additional 48 weeks
– GAIN Trial to continue as planned following
pre-specified DMC safety data review
Cortexyme, Inc. (Nasdaq: CRTX), 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 and other degenerative diseases,
today announced it is initiating an open-label extension study in
the United States for its Phase 2/3 GAIN Trial of COR388 in
subjects with mild to moderate Alzheimer’s disease (AD).
Additionally, the GAIN Trial Data Monitoring Committee recently
completed its first planned safety review and recommended
continuation of the study as planned.
“We are pleased to begin an open-label extension study of COR388
and, in doing so, facilitate the opportunity for subjects in the
GAIN Trial to continue to participate in research directed at
bringing forward a new potential therapeutic option for Alzheimer’s
disease,” said Michael Detke, M.D., Ph.D., Cortexyme’s Chief
Medical Officer. “We anticipate that the open-label extension of
the GAIN Trial will supply valuable data on the safety and clinical
activity of COR388 in a larger population of patients, for a longer
period of time, and will allow subjects randomized to placebo in
the GAIN Trial the opportunity to experience treatment with
COR388.”
The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s
Disease) Trial is based on a growing body of scientific evidence
showing that the pathogen Porphyromonas gingivalis, or P.
gingivalis, most commonly associated with chronic periodontal
disease, and its secreted proteases called gingipains can
infiltrate the brain and cause AD. The randomized, double-blind,
placebo-controlled trial is evaluating the efficacy, safety, and
tolerability of COR388, Cortexyme’s investigational gingipain
inhibitor, in patients with mild to moderate AD. The GAIN Trial has
been ongoing since the second quarter of 2019, with top-line
results expected in the fourth quarter of 2021.
Upon completing the 48-week placebo-controlled period of the
GAIN Trial, participants in the United States may be eligible to
enroll in the open-label extension study, where they will receive
COR388 for an additional 48 weeks. During the open-label extension
study, safety will be monitored and additional assessments
including cognitive tests will be performed. In Phase 1a/1b
testing, Cortexyme previously reported favorable safety,
tolerability and pharmacokinetics as well as positive biomarker
results demonstrating positive trends in patients with AD.
For more information on the GAIN Trial, visit
www.gaintrial.com.
About Cortexyme, Inc.
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/20200113005313/en/
Hal Mackins For Cortexyme, Inc. hal@torchcomllc.com (415)
994-0040
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