Cognition Therapeutics, Inc., (Nasdaq: CGTX), (the “Company” or
“Cognition”) announced upcoming presentations from studies of
CT1812, the Company's lead candidate for the treatment of adults
with early, mild and moderate Alzheimer’s disease at the Clinical
Trials on Alzheimer’s Disease (CTAD) conference being held October
24-27, 2023 virtually and in person in Boston, MA.
Cognition scientists and collaborators will present the complete
electroencephalography (EEG) findings and proteomic analyses from
the SEQUEL study. Prior topline results showed that CT1812 had a
beneficial impact on synapse function as measured by a positive
change in brain waves patterns observed using quantitative EEG.
Specifically, participants treated with CT1812 exhibited fewer slow
“theta” waves, which are associated with cognitive impairment, and
proportionally more “alpha” waves compared to placebo-treated
participants. CT1812 also improved connectivity, as assessed by
alpha AECc, which may indicate improved communication between
different parts of the brain.
An oral late-breaking presentation will also discuss the Phase 2
study design of the company’s ongoing START study, which is
enrolling adults with early Alzheimer’s disease. Participants in
START will be permitted to be on stable background therapy with
lecanemab, an FDA-approved anti-amyloid antibody.
“The approval of monoclonal antibody therapies against amyloid
beta (Aβ) protofibrils represents an important milestone in
Alzheimer’s drug development, but industry experts agree that
combination treatments will likely be required to achieve greater
impact on the disease,” explained Anthony Caggiano, MD, Ph.D.,
Cognition’s CMO and head of R&D. “To this end, we and our
colleagues at the National Institute of Aging and the Alzheimer’s
Clinical Trials Consortium (ACTC) made the strategic decision to
allow participants to enroll in the ongoing Phase 2 START study who
are being administered lecanemab. We believe this will allow us to
assess the benefit of CT1812 in real-world conditions.”
Cognition Therapeutics at CTAD:
Title: |
A
Pilot Electroencephalography (EEG) Study to Evaluate the Effect of
CT1812 Treatment on Synaptic Activity in Subjects with Mild to
Moderate Alzheimer's Disease (LP024) |
Authors: |
De Haan W, Caggiano AO, Scheltens
P, Grundman M, Scheijbeler E, Hamby ME, Vijverberg E |
|
|
Title: |
Proteomic Analysis of Plasma in a
Phase 2 Clinical Trial in Alzheimer’s Patients to Identify
Pharmacodynamic Biomarkers of the S2R Modulator CT1812 (P075) |
Authors: |
Lizama B, Cho E, Duong D, Pandey
K, Williams C, Caggiano AO, Seyfried N, Di Caro V, Hamby ME |
|
|
Title: |
Proteomic Analysis in a Phase 2
Clinical Trial Studying CT1812 to Identify CSF and Plasma
Pharmacodynamic Biomarkers and Molecular Correlates of EEG in
Alzheimer’s Patients (LP057) |
Authors: |
Di Caro V, Pandey K, Lizama B,
Cho E, Duong D, De Haan W, Grundman M, Seyfried N, Caggiano AO,
Vijverberg E, Hamby ME |
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|
Title: |
CT1812 START Study Design:
Anti-Aβ Monoclonal Antibodies as Background Therapy (LB18) |
Authors: |
van Dyck CH, Raman R, Donohue MC,
Rissman RA, Rafii MS, Hamby ME, Grundman M, Caggiano AO, Aisen
PS |
Session: |
Friday, October 27 |
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About CT1812 CT1812 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 SEQUEL Study The SEQUEL study
enrolled 16 adults with mild-to-moderate Alzheimer’s disease (MMSE
18-26), each of whom were randomized to receive either CT1812 or
placebo once daily for 28 days. After a 14-day wash-out period,
participants cross over into the other treatment arm for an
additional 28 days. SEQUEL was designed to assess the safety and
efficacy of CT1812 and to measure the impact of CT1812 on the
electrical activity in the brain, specifically those electrical
impulses in the theta band. SEQUEL was supported by $5.3
million in grant awards by the National Institute of Aging
(R01AG058710). More information may be found on
https://clinicaltrials.gov.
About the START StudyThe 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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