Cortexyme Provides Business Update and Reports Second Quarter 2021 Results
August 09 2021 - 7:00AM
Business Wire
GAIN Trial top-line data for disease
modification in Alzheimer’s expected by mid-November 2021
Phase 2 REPAIR sub-study results evaluating
periodontal disease expected by mid-November 2021
Current cash position sufficient to fund
operations through 2023
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 provided an update on expected
clinical top-line data and reported second quarter 2021 financial
results.
“Evidence demonstrating a causal link between the infectious
pathogen P. gingivalis and neurodegeneration continues to grow. We
are pleased with the rigorous and efficient execution of the GAIN
trial and are excited to be rapidly approaching such a significant
milestone for our industry. By following the evidence, we have
developed a potential therapeutic with a breakthrough mechanism of
action upstream of multiple aspects of Alzheimer’s disease
pathology including inflammation and neurodegeneration. We look
forward to sharing a robust top-line data set by mid-November
2021,” said Casey Lynch, Cortexyme’s chief executive officer,
co-founder, and chair.
“We believe positive data from the GAIN Trial could
fundamentally shift the paradigm of neurodegeneration research and
disease-modifying treatment in the Alzheimer’s field and we intend
to rapidly pursue collaboration with the FDA for the benefit of
patients. Cortexyme is confident that we have enrolled the right
population and that the study is powered to show a meaningful
treatment effect. We remain steadfast in our mission to provide
real change for Alzheimer’s patients and their caregivers,” said
Michael Detke, MD, PhD, Cortexyme’s chief medical officer.
Pivotal GAIN Trial Top-line Data Expected by Mid-November
2021
Cortexyme is pioneering an innovative, upstream,
disease-modifying therapeutic approach to Alzheimer's disease with
the company’s pivotal Phase 2/3 GAIN Trial that enrolled 643
patients with mild to moderate Alzheimer’s disease, in addition to
its Phase 2 periodontal disease REPAIR sub-study in 233 patients.
Less than 100 participants are pending treatment completion in the
study. The following are key highlights as the company readies for
its GAIN and REPAIR top-line data:
- The GAIN Trial is powered at approximately 90% to show a 50%
slowing of decline as measured by the cognitive and functional
co-primary clinical endpoints of ADAS-Cog11 and ADCS-ADL.
- Top-line data will also include other secondary and exploratory
clinical measures and biomarker data to support disease
modification in addition to key safety and tolerability
outcomes.
- The Phase 2 periodontal disease REPAIR sub-study of the GAIN
Trial evaluates standard clinical endpoints of periodontitis,
including gingival pocket depth, clinical attachment level, and
bleeding on probing.
- GAIN Trial baseline demographics confirm a representative
patient population of mild to moderate Alzheimer’s participants,
including the ratio of female patients (57% female to 42% male), a
balance of mild and moderate patients (50% mild and 50% moderate
based on MMSE measure), a representative proportion of ApoE4
carriers (64%), and approximately three-fourths (74%) of patients
using cholinesterase inhibitors/memantine for the treatment of
Alzheimer’s disease symptoms. Importantly, the GAIN Trial includes
higher than average diversity with approximately 20% representation
from Black and African American, Hispanic and Latino, and patients
of other racial and ethnic backgrounds.
Scientific and Pipeline Updates
- Cortexyme continued to expand its evidence base by presenting
new data at the International Association for Dental Research
(IADR) 2021 demonstrating atuzaginstat disrupts biofilms and is
efficacious in preclinical models of periodontal disease.
Atuzaginstat penetrates and disrupts bacterial biofilms, a key
feature for efficacy in treating P. gingivalis driven disease. Data
presented also demonstrated that atuzaginstat reverses alveolar
bone loss in mice after oral P. gingivalis infection at doses
relevant for therapeutic efficacy in periodontal disease.
- At the Alzheimer's Association International Conference® 2021
(AAIC®), Cortexyme presented preclinical data linking P. gingivalis
to elevated levels of p-tau217, reinforcing evidence of the
infectious pathogen as a causative agent of Alzheimer’s disease,
and these elevations were prevented by treatment with atuzaginstat.
In addition, newly presented GAIN Trial baseline data demonstrates
that a majority of patients have elevated serum Von Willebrand
factor, a marker of endothelial cell injury, and
alpha-2-macroglobulin, an endogenous protease inhibitor.
- Cortexyme successfully completed IND enabling studies of
COR588, including nonclinical safety and two-month toxicology
studies. First-in-human studies are on schedule to begin in the
third quarter 2021.
- The company announced the selection of a lead 3CLpro inhibitor
(COR803) for the treatment of coronavirus infections, including
COVID-19 disease, caused by SARS-CoV-2 infection. COR803 is a novel
patent-pending small molecule 3CLpro inhibitor. 3CLpro, or Mpro, is
a viral cysteine protease and validated drug target shown to be
essential in replication of SARS-CoV-2. We believe COR803 has
potentially beneficial properties over other COVID-19 therapeutics
and 3CLpro inhibitors in development including: covalent
irreversible binding of the viral 3CLpro enzyme; high potency;
antiviral EC90 of 30 nM in human lung cell viral replication
assays; highly selective for 3CLpro versus other cellular proteases
including Cathepsin L; and excellent systemic exposure utilizing
intranasal or subcutaneous administration, allowing for clinical
use in multiple settings such as outpatient and inpatient.
Second Quarter 2021 Financial Results
- Cash Position: Cash, cash equivalents, and short and long-term
marketable securities as of June 30, 2021, were $153.5 million.
Cortexyme expects its cash position to be sufficient to fund its
operating and capital expenditures through 2023.
- Research and Development (R&D) Expenses: For the quarter
ended June 30, 2021, R&D expenses were $14.7 million primarily
due to costs related to the research and development of
atuzaginstat, the GAIN Trial, COR588, and personnel-related
expenses.
- General and Administrative (G&A) Expenses: For the quarter
ended June 30, 2021, G&A expenses were $7.1 million. The
expenses were primarily attributable to personnel-related expenses,
insurance, and professional and legal fees.
- Net Loss: For the quarter ended June 30, 2021, the company’s
net loss was $21.8 million, or a loss of $0.74 per basic share.
Weighted average shares outstanding for the quarter ended June 30,
2021, were 29,587,352.
About The GAIN Trial
Cortexyme’s seminal discovery, along with confirmatory clinical
and preclinical studies, demonstrate that the intracellular
pathogen, P. gingivalis, is found in the brain of more than 90% of
Alzheimer’s patients and that an oral infection with P. gingivalis
in animals results in brain infiltration and downstream hallmark
Alzheimer’s pathologies, including Aβ42 production, tau
hyperphosphorylation, microglial activation, and neurodegeneration.
The company’s lead drug candidate, atuzaginstat (COR388), is a
first-in-class, orally administered, brain penetrant small molecule
targeting P. gingivalis, which is upstream of neuronal death and
Alzheimer’s disease pathology. Atuzaginstat blocks gingipains,
protease virulence factors secreted by P. gingivalis, which are
required for its survival and responsible for its toxicity. The
GAIN Trial also includes a REPAIR sub-study of 233 patients
targeting P. gingivalis – most commonly known as a keystone
bacterium associated with periodontal disease – and measuring the
efficacy of atuzaginstat on clinical endpoints of periodontal
disease. Cortexyme’s innovative therapeutic approach continues to
be supported by research from laboratories around the world
published in peer-reviewed scientific journals.
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 the sufficiency of its
cash position to fund its operations; its business plans, strategy,
timeline, prospects, and milestone expectations; 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 potential of COR803 to treat coronavirus
infections; 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/20210809005203/en/
Stacy Roughan Cortexyme, Inc. Vice President, Corporate
Communications & Investor Relations ir@cortexyme.com
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