Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that
Christoper van Dyck, M.D., the director of the Yale Alzheimer's
Disease Research Unit and the Yale Alzheimer's Disease Research
Center, is presenting the Phase 2 study design of the company’s
ongoing START study in an oral late-breaking session at Clinical
Trials on Alzheimer’s Disease (CTAD) conference. The START
Study is assessing once-daily oral CT1812 or placebo in 540
individuals with early Alzheimer’s disease for 18 months of
treatment. Cognition Therapeutics is conducting the study in
collaboration with the Alzheimer's Clinical Trials Consortium
(ACTC) with major grant support from the National Institute of
Aging (NIA) at the National Institutes of Health.
“This study represents the next generation of trials for
Alzheimer’s disease, in that participants who are on stable doses
of the first fully approved disease-modifying treatment for
Alzheimer’s disease - lecanemab (an anti-amyloid antibody) - will
be eligible to enroll, in addition to those who have not been
exposed to lecanemab,” explained Dr. van Dyck, who is also a member
of the ACTC executive committee and the project director of the
START Study. “The future treatment of Alzheimer’s disease will
likely consist of combination therapies to achieve greater slowing
of disease progression. My colleagues and I are excited about the
prospects of an oral treatment like CT1812, which may prove to be
effective as a monotherapy but also has a mechanism of action that
is distinct from and potentially complimentary to the anti-amyloid
antibodies."
Published data points to a role for the sigma-2 (σ-2) receptor
in regulating key “housekeeping” processes such as autophagy that
are impaired in Alzheimer’s and other neurodegenerative diseases.
By binding to the σ-2 receptor on neurons, CT1812 may rescue these
processes and protect neurons from further damage. We have
collected the following clinical data, which we believe support the
potential benefit that CT1812 may exert on synapse function and
overall brain health:
- target engagement data demonstrated in the SNAP study;
- preliminary evidence of cognitive impact seen in the first
cohort of patients in the SHINE study;
- reduced hippocampal atrophy (loss of brain matter) observed via
volumetric MRI in the SPARC study; and
- favorable impact on brainwave patterns as measured via
quantitative electroencephalogram in the Phase 2 SEQUEL study.
The tolerability profile of CT1812 has been consistent
throughout clinical development with mild-to-moderate adverse
events and no treatment-related serious adverse events
reported.
The START study is actively underway with screening of adults
with early Alzheimer’s disease at multiple clinical sites,
including the University of Kentucky Sanders-Brown Center on Aging
(SBCoA), the Butler Hospital Memory and Aging Program (BHMAP), and
Wake Forest University Health Sciences. Ultimately, we expect that
approximately 50 sites in North America, including premier
institutions in the ACTC network, will be activated.
"A once-daily oral medication that could slow or halt the
progression of this disease at an early stage would add an
important therapeutic option for physicians and patients alike,"
added Cognition president and CEO, Lisa Ricciardi. "This trial
gives us the opportunity to study CT1812 in patients with early
stages of Alzheimer’s disease, when the proposed synapto-protective
mechanism of CT1812 may shield neurons from further injury. We
believe that a trial that reflects the future real-world population
of individuals who are on or have been exposed to anti-amyloid
antibodies, will allow for clinically relevant findings from the
study."
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. CT1812 is currently in
development for mild-to-moderate Alzheimer’s disease in the SHINE
study (NCT03507790), early Alzheimer’s disease in the START study
(NCT05531656), and dementia with Lewy bodies in the SHIMMER study
(NCT05225415).
About the START StudyThe START study will
measure the efficacy and tolerability of once-daily oral CT1812 in
individuals with mild cognitive impairment or early Alzheimer’s
disease (MMSE 20-30) who have elevated Aβ (as measured by PET or
CSF). Participants will be randomized to receive CT1812 or placebo
for 18 months. The study will assess cognition and executive
function using validated tools including the Clinical Dementia
Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales, as
well as biomarker and safety findings.
The START study is supported by a grant from the National
Institute of Aging (NIA) at the National Institutes of Health
(R01AG065248). The study is being conducted in collaboration with
the Alzheimer's Clinical Trials Consortium (ACTC), an NIA-funded
(grant number U24AG057437) clinical trial network of 35 leading
academic sites with expertise in clinical trials in Alzheimer's
disease. More information may be found at
https://start-study.org.
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 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
https://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, including CT1812, and 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, 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 described more fully 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 |
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