Cortexyme Expands Proprietary Development Pipeline with Initiation of Phase 1 Clinical Trial of COR588
September 08 2021 - 7:00AM
Business Wire
First participants dosed in clinical trial of
second-generation gingipain inhibitor differentiated by novel
compound properties and anticipated once daily administration
Clinical advancement of pipeline delivers on
commitment to bring innovation to an increasing range of P.
gingivalis-related disease indications with high unmet clinical
needs
Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal
trial in Alzheimer’s disease with top-line data expected by
mid-November 2021 and a growing pipeline of therapeutics for
degenerative diseases, today announced that the first cohort of
healthy participants have been dosed in the Phase 1 clinical trial
of its new drug candidate, COR588. COR588 is a second-generation
small-molecule lysine-gingipain inhibitor differentiated from the
company’s lead drug candidate atuzaginstat (COR388) by its improved
pharmacokinetic properties and anticipated once daily oral
administration. Delivering on its commitment to bring innovation to
high unmet clinical needs, Cortexyme expects COR588 to be targeted
for use in the treatment of periodontal disease and other P.
gingivalis-related indications.
“Advancing COR588 into the clinic as planned marks an important
milestone for Cortexyme as we expand our proprietary drug pipeline
and strategically advance our first-in-class gingipain inhibitors
for additional indications where the evidence demonstrates P.
gingivalis plays a critical role in disease progression,” said
Casey Lynch, Cortexyme’s chief executive officer, co-founder, and
chair. “Based on this wealth of research, we believe our innovative
upstream therapeutic approach has the potential to shift the
paradigm for the treatment of diseases with high unmet clinical
need in distinct market segments. Building on the momentum of our
successfully completed IND-enabling studies of COR588, we look
forward to completing the Phase 1 study and advancing the clinical
studies of this promising potential therapeutic.”
Sponsored by Cortexyme, the COR588 Phase 1 trial is a
randomized, double-blind, placebo-controlled, first-in-human study
to evaluate the safety, tolerability, and pharmacokinetics of
single and multiple ascending doses of oral COR588 capsules in
healthy adult patients. The trial will enroll up to 64 participants
and is listed under clinicaltrials.gov Identifier: NCT04920903.
Future studies will evaluate the ability of COR588, an oral
investigational medicine, to slow or halt the progression of
periodontal disease, among other potential indications, by
inactivating the toxic proteases, or gingipains, released by the
keystone bacterium P. gingivalis. Periodontal disease represents a
major unmet medical need impacting 65 million Americans.
Therapeutic effects of gingipain inhibitors have been demonstrated
in both mouse and naturally occurring aged dog models (Arastu-Kapur
et al, 2020).
Cortexyme is evaluating the efficacy of its lead
lysine-gingipain inhibitor, atuzaginstat, in the company’s pivotal
GAIN Trial evaluating the role of P. gingivalis in the progression
of Alzheimer’s disease in mild to moderate patients, which includes
a 233-patient sub-study in periodontal disease called REPAIR
(REduction of P. GingivAlIs to ImpRove Pocket Depth). Top-line data
from the GAIN Trial and REPAIR sub-study are expected by
mid-November 2021.
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. The company is
advancing its disease-modifying pivotal GAIN Trial in mild to
moderate Alzheimer's disease with top-line data expected by
mid-November 2021, in addition to growing a proprietary pipeline of
first-in-class small molecule therapeutics for Parkinson’s disease,
periodontitis, and other diseases with high unmet clinical need.
Cortexyme’s lead program targets a specific, infectious pathogen
called P. gingivalis found in the brain 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, statements Cortexyme makes regarding its business plans,
strategy, timeline, prospects, and milestone expectations; the
characteristics and potential benefits of COR588, including for the
treatment of periodontal disease; the timing and success of the
company’s clinical trials and related data, including with respect
to the GAIN and REPAIR Trials, 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, regulatory submissions 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210908005279/en/
Cortexyme Contact: Stacy Roughan Cortexyme, Inc. Vice
President, Corporate Communications & Investor Relations
ir@cortexyme.com
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