Cortexyme Reports Safety and Pharmacokinetics Results from Single Ascending Dose Portion of its Phase 1 Clinical Trial of COR588
09 March 2022 - 12:00AM
Business Wire
COR588 well-tolerated in all dose cohorts
Human pharmacokinetics support once daily oral
dosing
Multiple ascending dose data expected in the
second quarter of 2022
Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage
biopharmaceutical company pioneering upstream therapeutic
approaches to improve the lives of patients diagnosed with
degenerative diseases, today announced results from the single
ascending dose (SAD) portion of the Phase 1 clinical trial of its
new drug candidate COR588, a next generation, oral, small-molecule
lysine gingipain inhibitor in development for the treatment of
diseases related to P. gingivalis infection. The SAD trial was
designed to evaluate the safety and pharmacokinetics of COR588 in
healthy volunteers.
In the SAD portion of the Phase 1 trial, preliminary results
indicate COR588 was well-tolerated across all four cohorts in the
dose range from 25 mg to 200 mg with no serious adverse events. No
clinically significant findings were observed on other safety
measures, including vital signs, laboratory findings, telemetry, or
ECGs. In the study, COR588 exhibited an 11-to-12-hour half-life
consistent with once daily dosing and a dose-proportional
pharmacokinetic profile that achieved and exceeded the targeted
exposure predicted for therapeutic efficacy.
“COR588 was designed to be a potent and selective molecule with
pharmacokinetics supportive of once daily oral dosing and these
data support continued development,” said Michael Detke, MD, PhD,
Cortexyme’s chief medical officer. “We are encouraged by the
initial safety results and look forward to sharing the full data
set from the COR588 Phase 1 trial in the second quarter of 2022
once the multiple ascending dosing phase is complete.”
COR588 Phase 1 Trial Overview
COR588 is a selective, oral small-molecule inhibitor of lysine
gingipains, protease virulence factors secreted by P. gingivalis,
and is being developed for patients with disorders related to P.
gingivalis infection, including Alzheimer’s disease. The clinical
trial of COR588 has now progressed to the second portion of this
Phase 1 study, with a multiple ascending dose (MAD) evaluation of
three cohorts: 50 mg, 100 mg, and 200 mg of COR588 versus placebo,
once daily for 10 days. Cortexyme expects to present the full data
set from the COR588 Phase 1 clinical trial in the second quarter of
2022.
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 participants. The SAD portion of the trial included
32 enrolled participants, and the full trial 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 Alzheimer’s disease, among other
potential indications, by inactivating the proteases, or
gingipains, released by the keystone bacterium P. gingivalis.
Therapeutic effects of gingipain inhibitors have been demonstrated
in humans in the GAIN Trial, in addition to both mouse (Dominy et
al, 2019) and naturally occurring aged dog models (Arastu-Kapur et
al, 2020).
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,” “will,” “may,” “should,” “estimate,” “project,”
“potential,” “encouraged,” or other similar words. Examples of
forward-looking statements include, among others, the strategic
development path for COR588 including with regard to the Phase 1
clinical trial; its business plans, internal and external
development of the pipeline, strategy, planned FDA submissions and
clinical trials and timeline, prospects, and milestone
expectations; the timing and success of the company’s clinical
trials and related data, including plans and the ability to
initiate, conduct and/or complete current and additional studies;
the potential of COR588 to treat Alzheimer’s disease and other
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
other programs or indications, regulatory submissions and
interactions with regulators, and related response and decisions,
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, 2022, its Quarterly Report on Form 10-Q filed with the SEC
on October 29, 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/20220308005365/en/
Stacy Roughan Cortexyme, Inc. Vice President, Corporate
Communications & Investor Relations ir@cortexyme.com
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