Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that the
first clinical trial site has been activated and can begin
recruiting participants for the 540-patient Phase 2 START study of
CT1812 in adults with early Alzheimer’s disease. The University of
Kentucky Sanders-Brown Center on Aging (SBCoA) is the first of
approximately 50 sites in North America that has been activated by
the Alzheimer's Clinical Trials Consortium (ACTC). The ACTC,
founded in 2018 with funding from the National Institute on Aging
(NIA), part of the National Institutes of Health, is one of the
NIA’s largest public-private partnerships.
“Our START study represents a unique and important opportunity
for Cognition to study CT1812 in people with early Alzheimer's
disease,” added Cognition president and CEO, Lisa Ricciardi. While
trials in this patient population are crucial, the long treatment
period required to show a change in cognition can be overly
burdensome for small biotechnology companies. Without the support
of the ACTC and the NIA's $81 million grant, we would likely not be
in a position to offer these research participants the opportunity
to test an oral once-daily medication that may slow the progression
of Alzheimer's disease. It is incredibly exciting and humbling to
have reached the stage where patient recruitment can finally
begin.”
The randomized placebo-controlled START trial is being conducted
at approximately 50 sites in North America including over 30
premier academic institutions that are part of the ACTC network. An
estimated 540 adults with early Alzheimer’s disease (MMSE 20-30)
who have elevated beta amyloid (Aβ) will be randomized to receive
once-daily oral CT1812 or placebo for 18 months. CT1812 is an
investigational oral, small molecule designed to bind to a receptor
on synapses and prevent the toxic effects of soluble Aβ oligomers
on neurons.
“The hard work from our dedicated team of clinical
program managers, statisticians, biomarker experts, and
recruitment, retention and diversity leaders has paid off with the
activation of the site at the SBCoA,” concluded Paul Aisen, M.D.,
professor of neurology at the University of Southern California and
director of the Alzheimer's Therapeutic Research Institute. “We’re
looking forward to partnering with the team at SBCoA and other
investigators who are working to bring their sites online so we can
begin screening people with early Alzheimer’s disease who are
interested in becoming participants in the START study.”
To date, CT1812 has been studied in over 200 healthy volunteers
and adults with Alzheimer's disease or dementia with Lewy bodies
(DLB). The tolerability profile of CT1812 has been consistent
throughout clinical development. Most adverse events have been mild
to moderate in severity with no deaths and no treatment-related
serious adverse events reported. We have observed mild and
transient elevations of liver enzymes without any other indications
of liver injury, which returned to normal after cessation of
treatment.
More information about the START study may be found on
www.clinicaltrials.gov under trial identifier NCT05531656.
About CT1812CT1812 is an experimental, orally
delivered, small molecule designed to penetrate the blood-brain
barrier and bind selectively to the sigma-2 (σ-2) receptor complex.
The σ-2 receptor complex is involved in the regulation of key
cellular processes such as membrane trafficking and autophagy that
are damaged by toxic interaction with Aβ oligomers, oxidative
stress and other stressors. This damage to sensitive synapses can
progress to a loss of synaptic function, which manifests as
cognitive impairment and Alzheimer’s disease progression. CT1812 is
currently in development for mild-to-moderate Alzheimer’s disease
in the SHINE study (NCT03507790) and dementia with Lewy bodies in
the SHIMMER study (NCT05225415).
About the Alzheimer's Clinical Trials Consortium
(ACTC)The ACTC, funded by the National Institute on Aging
at the National Institutes of Health (grant number U24AG057437),
provides the infrastructure for academic clinical trials in
Alzheimer's disease and related dementias. The consortium, jointly
based at the University of Southern California, Harvard University
and the Mayo Clinic, includes expert units to support clinical
trial design, biostatistics, informatics, medical safety,
regulatory oversight, recruitment, clinical operations, data
management, site monitoring, a biomarker laboratory and repository
and neuroimaging. The ACTC includes 35 primary clinical sites
across the United States.About Cognition Therapeutics,
Inc.Cognition Therapeutics, Inc. is a clinical-stage
biopharmaceutical company engaged in the discovery and development
of innovative, small molecule therapeutics targeting age-related
degenerative disorders of the central nervous system and retina. We
are currently investigating our lead candidate CT1812 in clinical
programs in Alzheimer’s disease, dementia with Lewy bodies (DLB)
and dry age-related macular degeneration (dry AMD). We believe
CT1812 and our pipeline of investigational σ-2 receptor modulators
can regulate pathways that are impaired in these diseases. We
believe that targeting the σ-2 receptor with CT1812 represents a
mechanism functionally distinct from other current approaches in
clinical development for the treatment of degenerative diseases.
More about Cognition Therapeutics and its pipeline can be found
at http://cogrx.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release, other than statements of
historical facts or statements that relate to present facts or
current conditions, including but not limited to, statements
regarding our product candidates, any expected or implied benefits
or results, including that initial clinical results observed with
respect to CT1812 will be replicated in later trials and our
clinical development plans, including statements regarding our
Phase 2 START study of CT1812, are forward-looking statements.
These statements, including statements relating to the timing and
expected results of our clinical trials involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance, or achievements to be materially
different from any future results, performance, or achievements
expressed or implied by the forward-looking statements. In some
cases, you can identify forward-looking statements by terms such as
“may,” might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,”
“anticipate,” “could,” “intend,” “target,” “project,”
“contemplate,” “believe,” “estimate,” “predict,” “forecast,”
“potential” or “continue” or the negative of these terms or other
similar expressions. We have based these forward-looking statements
largely on our current expectations and projections about future
events and financial trends that we believe may affect our
business, financial condition, and results of operations. These
forward-looking statements speak only as of the date of this press
release and are subject to a number of risks, uncertainties and
assumptions, some of which cannot be predicted or quantified and
some of which are beyond our control. Factors that may cause actual
results to differ materially from current expectations include, but
are not limited to: competition; our ability to secure new (and
retain existing) grant funding; our ability to grow and manage
growth, maintain relationships with suppliers and retain our
management and key employees; our ability to successfully advance
our current and future product candidates through development
activities, preclinical studies and clinical trials and costs
related thereto; uncertainties inherent in the results of
preliminary data, pre-clinical studies and earlier stage clinical
trials being predictive of the results of early or later stage
clinical trials; the timing, scope and likelihood of regulatory
filings and approvals, including regulatory approval of our product
candidates; changes in applicable laws or regulations; the
possibility that the we may be adversely affected by other
economic, business or competitive factors, including ongoing
economic uncertainty; our estimates of expenses and profitability;
the evolution of the markets in which we compete; our ability to
implement our strategic initiatives and continue to innovate our
existing products; our ability to defend our intellectual property;
the impact of the COVID-19 pandemic on our business, supply chain
and labor force; and the risks and uncertainties more fully
described in the “Risk Factors” section of our annual and quarterly
reports filed with the Securities Exchange Commission and are
available at www.sec.gov. These risks are not exhaustive and we
face both known and unknown risks. You should not rely
on these forward-looking statements as predictions of future
events. The events and circumstances reflected in our
forward-looking statements may not be achieved or occur, and actual
results could differ materially from those projected in the
forward-looking statements. Moreover, we operate in a dynamic
industry and economy. New risk factors and uncertainties may emerge
from time to time, and it is not possible for management to predict
all risk factors and uncertainties that we may face. Except as
required by applicable law, we do not plan to publicly update or
revise any forward-looking statements contained herein, whether as
a result of any new information, future events, changed
circumstances or otherwise.
Contact Information:
Cognition Therapeutics, Inc.info@cogrx.com
Casey McDonald (media)Tiberend Strategic Advisors,
Inc.cmcdonald@tiberend.com
Daniel Kontoh-Boateng (investors)Tiberend Strategic Advisors,
Inc.dboateng@tiberend.com
Cognition Therapeutics (NASDAQ:CGTX)
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Cognition Therapeutics (NASDAQ:CGTX)
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