Cortexyme Announces European Screening Now Underway in the Phase 2/3 GAIN Trial
September 26 2019 - 8:00AM
Business Wire
- International study is evaluating whether a
new investigational medicine targeting P. gingivalis bacteria can
slow or halt the progression of Alzheimer’s disease
- GAIN Trial opened for U.S. enrollment in Q2
2019 and is expected to include approximately 90 sites globally
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 the start of screening in Europe for the GAIN
(GingipAIN Inhibitor for Treatment of Alzheimer’s Disease) Trial,
the company’s ongoing Phase 2/3 clinical study of lead
investigational medicine COR388 in subjects with mild to moderate
Alzheimer’s disease (AD). The international trial has been
enrolling in the United States since the second quarter of 2019 and
is targeting enrollment of approximately 570 subjects. Potential
participants and their caregivers can learn more about the trial at
www.GAINtrial.com.
“Based upon our evidence to date, the GAIN Trial was designed to
assess the safety and efficacy of COR388 against an upstream target
of neurodegeneration, which we believe is foundational to
addressing Alzheimer’s disease,” said Michael Detke, M.D., Ph.D.,
Cortexyme’s chief medical officer. “We are excited to further
examine the role gingipains play in the development of Alzheimer’s
disease, and whether targeting these toxic proteases can slow or
stop disease progression.”
The GAIN Trial is based on the growing body of scientific
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. The
trial evaluates the ability of COR388, an investigational medicine
designed to inactivate the toxic proteases, or gingipains, released
by the bacteria, to stop or slow further damage to brain cells.
Prior clinical studies of COR388 showed the compound was
well-tolerated and identified positive trends across biomarkers and
cognitive tests in subjects with AD.
“We must leave no stone unturned in the search for an effective
Alzheimer’s therapeutic, and the data to support testing COR388 is
compelling,” said Bruno Vellas, M.D., Ph.D., head of the Alzheimer
Disease Clinical Research Centre at the University of Toulouse. “We
are glad to be a site for this important study and look forward to
supporting the best path forward for patients.”
About the GAIN Trial
The GAIN Trial is a Phase 2/3 randomized, double-blind,
placebo-controlled study assessing the efficacy, safety, and
tolerability of two dose levels of COR388 oral capsules in subjects
with mild to moderate AD. Randomized participants enter a screening
period of up to six weeks, a 48-week treatment period, and a safety
follow-up period of an additional six weeks. The primary endpoint
for the study is mean change in the Alzheimer’s Disease Assessment
Scale-Cognitive Subscale 11 (ADAS-Cog 11) from baseline to 48
weeks. Secondary and exploratory endpoints include change in
Alzheimer’s Disease Cooperative Study Group-Activities of Daily
Living (ADCS-ADL), change in Clinical Dementia Rating-Sum of Boxes
(CDR-SB), Winterlight Speech Assessment, cerebral spinal fluid
biomarkers of infection, and other measures. Top-line results from
the trial are anticipated in the fourth quarter of 2021. More
information about the trial can be found at 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 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/20190926005306/en/
Hal Mackins For Cortexyme hal@torchcomllc.com (415) 994-0040
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