Cortexyme Successfully Completes Phase 1 Single and Multiple Ascending Dose Clinical Trial of COR588
July 27 2022 - 8:00AM
Business Wire
Once daily dose of COR588 over 10-day period
well-tolerated with no serious adverse events observed
Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage
biopharmaceutical company focused on advancing therapeutics for
rare and degenerative diseases, today reported the successful
completion of its Phase 1 single ascending dose and multiple
ascending dose (SAD/MAD) clinical trial of COR588, the company’s
lysine gingipain inhibitor in development for the treatment of
Alzheimer’s disease and indications with disease pathology
associated with the keystone pathogen P. gingivalis. The study was
a randomized, double-blind, placebo-controlled, first-in-human
study to evaluate the safety, tolerability, and pharmacokinetics of
COR588 in healthy adult participants.
Previously announced in March 2022, the SAD portion of the Phase
1 clinical trial demonstrated that COR588 was well-tolerated across
all cohorts in the dose range from 25 mg to 200 mg with no serious
adverse events. No clinically significant findings were observed on
safety measures, including vital signs, laboratory findings,
telemetry, or ECGs. No clinical chemistry or hematology safety
concerns were observed at any dose. Additionally, COR588 exhibited
an 11-to-12-hour half-life consistent with once daily dosing and a
dose-proportional pharmacokinetic profile that importantly achieved
the targeted exposure predicted for therapeutic efficacy.
The MAD portion of the Phase 1 clinical trial of COR588
demonstrated that once daily oral administration of COR588 over a
10-day period was well-tolerated across all cohorts in the dose
range from 50 mg to 200 mg with no serious adverse events observed.
High central nervous system penetration of COR588 was confirmed
after 10 days of administration.
Cortexyme will provide an update on the development path forward
for COR588 in conjunction with its planned corporate name change to
Quince Therapeutics and detailed go-forward growth strategy that is
expected to be announced on August 1, 2022.
About COR588
COR588 is a selective, oral small-molecule inhibitor of lysine
gingipains, protease virulence factors secreted by P. gingivalis,
and is being developed for the potential treatment of patients with
Alzheimer’s disease. Sponsored by Cortexyme, the COR588 Phase 1
clinical trial (Identifier: NCT04920903) was 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.
About Cortexyme
Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage
biopharmaceutical company focused on advancing therapeutics for
rare and degenerative diseases. The company’s innovative pipeline
includes a precision bone growth molecule and drug-targeting
platform to treat rare skeletal diseases, bone cancer and injury,
in addition to small molecule therapeutics targeting the infectious
pathogen P. gingivalis’ role in degenerative disease progression,
including indications such as periodontal disease, oral potentially
malignant disorders, squamous cell carcinoma, and Alzheimer’s
disease, among others. 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; its business plans, internal and
external development of the pipeline, strategy; 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 the
company's COR588 to treat Alzheimer’s disease and other
indications; and the potential therapeutic benefits, safety and
efficacy of the company’s product candidate or library of
compounds. 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 May 10, 2022, 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/20220727005254/en/
Cortexyme Contact: Stacy Roughan Cortexyme, Inc. Vice
President, Corporate Communications & Investor Relations
ir@cortexyme.com
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