Cognition Therapeutics Completes Enrollment in Phase 2 SHINE Study of CT1812 in Mild-to-Moderate Alzheimer’s Disease
November 07 2023 - 7:30AM
Cognition Therapeutics, Inc. (Nasdaq:
CGTX), (the “Company” or “Cognition”), today announced
that the last participant was randomized in the Phase 2 SHINE study
(NCT03507790) of CT1812, the company’s lead candidate for the
treatment of age-related neurodegenerative diseases of the CNS and
retina. A total of 153 adults with mild-to-moderate (MMSE 18-26)
Alzheimer's disease were randomized to receive either placebo or
oral doses of CT1812 (100 mg or 300 mg). Endpoints include safety,
change in cognitive function, as measured by ADAS-Cog 11 and
biomarker evidence of disease modification. Top-line results are
expected in mid 2024 after the last participants have completed six
months of treatment.
“Results of the SHINE trial will provide important information
on safety, tolerability and cognitive effects of CT1812 in people
with mild-to-moderate Alzheimer’s disease, and these results will
inform our plans for Phase 3 development,” Lisa Ricciardi,
president and CEO of Cognition Therapeutics stated. “Completing
enrollment in the trial ahead of our 2023 target allows us to bring
proof-of-concept results sooner and provides savings to our
company. We couldn’t have accomplished this without the support of
the study participants and caregivers as well as our investigators
and collaborators at the National Institute on Aging. We look
forward to seeing the full study results in mid 2024.”
An evaluation of the first 24 SHINE participants showed that
those treated with CT1812 experienced a slowing of cognitive
decline as measured by a three-point difference on the ADAS-Cog 11
scale compared to placebo. Overall, CT1812 was well tolerated and
adverse events were balanced across treatment groups, consistent
with the safety profile observed in previous clinical trials.
“Results from our initial clinical trials with CT1812 have shown
evidence of target engagement, a positive effect on
neurophysiological, anatomical and cognitive endpoints, and
biomarker evidence of an impact on underlying disease processes,”
added Anthony Caggiano, MD, Ph.D., CMO and head of R&D at
Cognition Therapeutics. “We are optimistic about these combined
findings and are looking forward to analyzing the final SHINE
results.”
The SHINE study was supported by two grant awards from the
National Institute on Aging of the National Institutes of Health
(NIH) totaling approximately $30 million.
About the SHINE StudyThe SHINE study is a
double-blind, placebo-controlled Phase 2 clinical trial designed to
enroll approximately 144 patients with mild-to-moderate Alzheimer’s
disease. Participants are evenly randomized to receive either
placebo or one of two doses of CT1812 (100 mg or 300 mg), which is
taken orally daily for six months. Endpoints include safety,
cognitive function as measured by the ADAS-Cog 11, a globally
recognized cognitive scale, and biomarker evidence of disease
modification.
About CT1812CT1812 is an experimental orally
delivered small molecule that penetrates the blood-brain barrier
and binds selectively to the sigma-2 (σ-2) receptor complex.
Preclinical and clinical data demonstrate that this binding results
in the displacement of toxic Aβ oligomers. 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.
Participants are currently being recruited in the SHIMMER study
(NCT05225415) of CT1812 in adults with dementia with Lewy bodies;
the START study (NCT05531656) of CT1812 in adults with early
Alzheimer’s disease; and the MAGNIFY study (NCT05893537) in adults
with geographic atrophy (GA) secondary to dry age-related macular
degeneration.
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 Statements This 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
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relating to the timing and expected results of our clinical trials
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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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