- Coya reports new data illustrating that administration of COYA
301 (low dose Interleukin-2 (IL-2)) in an open- label study in 8
patients with mild to moderate AD (COYA 301 Trial) resulted in a
statistically significant reduction in the expression of three well
characterized proinflammatory cytokines -- Tumor Necrosis Factor
alpha (TNF-α), Interleukin 6 (IL-6), and Interleukin 1- Beta
(IL-1β) -- which correlated with lack of cognitive decline of the
patients over the course of the study.
- TNF-α is one of the main inflammatory cytokines involved in
initiating and propagating an inflammatory response and its role in
the pathophysiology of AD has been documented. The proinflammatory
cytokines IL-6 and IL-1β have also been documented to play a
central role in AD and in the development of neuroinflammation and
induction of neuronal damage.
- Furthermore, Coya reports a case study of a patient in the COYA
301 trial who had pre-treatment and post-treatment Positron
Emission Tomography (PET) brain scans to evaluate
neuroinflammation. Meaningful reductions in neuroinflammation were
observed throughout the cerebral cortex including hippocampal
regions following treatment with COYA 301, which correlated with
improvement in cognitive function in this patient.
- Coya previously reported that patients in the COYA 301 trial
achieved a statistically significant improvement in cognitive
function, as measured by the Mini-Mental State Examination test
(MMSE) and no cognitive decline when measured by the Alzheimer’s
Disease Assessment Scale–Cognitive Subscale (ADAS-Cog), and the
Clinical Dementia Rating-Sum of Boxes scale (CDR-SB).
- Coya also previously reported that treatment with COYA 301
restored peripheral Treg function and numbers, significantly
lowered the levels of systemic chemokines CCL11, CCL2, and cytokine
IL-15, and was well tolerated.
- An ongoing academic phase 2 double blind randomized trial
(supported by the Gates Foundation and Alzheimer’s Association) for
use of low dose IL-2 in up to 46 mild to moderate AD patients that
is underway at Houston Methodist (led by Alireza Faridar M.D. and
the Chair of Coya’s SAB, Stanley Appel, M.D.), should report top
line data in Q2 2024, and inform Coya on its strategy.
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
multiple therapeutic programs intended to enhance Treg function,
including biologics, today reported additional biomarker and brain
imaging results from an open-label proof-of-concept clinical study
for COYA 301 in patients with mild to moderate AD. Results of the
study will be presented June 7th, 2023, at the LD Micro Conference
in Los Angeles, CA. The clinical study data can be viewed here.
The open-label study enrolled 8 patients with confirmed presence
of brain amyloid pathology and baseline MMSE scores between 12 and
25. The patients were treated with five day-courses of COYA 301 for
four monthly cycles and were followed for two months
post-treatment. Treg function and numbers, serum biomarkers of
inflammation, and cognitive functioning as measured by the
ADAS-Cog, CDR-SB and MMSE assessment tools were evaluated.
Clinically, evaluation of cognitive function showed that
administration of COYA 301 resulted in a statistically significant
improvement in mean MMSE scores during the treatment phase,
compared to mean MMSE score at baseline (p=0.015). Consistent with
the positive trend in MMSE score, mean scores in ADAS-Cog and
CDR-SB scales did not significantly change at the end of treatment
with COYA 301, compared to pre-treatment baseline scores,
indicating no cognitive decline as measured by these validated
instruments.
In addition to COYA 301 administration resulting in a
statistically significant reduction of blood biomarkers CCL11,
CCL2, and IL-15. Today, we report statistically significant
reductions in the peripheral expression of the pro-inflammatory
cytokines TNF-α, IL-6, and IL-1β. These biomarkers are well
characterized in playing a central role in AD pathophysiology,
propagation of neuroinflammation, and contribution to neuronal
damage. The consistent reduction of these cytokines correlated with
lack of cognitive decline of the patients over the course of the
study. Further, the significant reduction of proinflammatory
cytokine expression and the lack of clinical decline also
correlated with significant increase of regulatory T cell function
following the administration of COYA 301.
One of the patients in the study underwent a pre- and
post-treatment PET brain scan using a radioligand for imaging 18
kDa translocator protein (TSPO), a biomarker for neuroinflammation.
Increased binding of TSPO to activated microglia in brain regions
is indicative of heightened inflammation and be observed with a
color code with red, orange, and yellow. In contrast, images in
green and blue indicate lower levels of neuroinflammation. In this
patient, the pre-treatment PET scan showed high levels of TSPO
binding indicative of inflammation throughout the cerebral cortex
in both sagittal and coronal views, including in hippocampal
regions. The PET scan after the last cycle of COYA 301 showed
marked reduction in TSPO binding across the brain representing
lowered inflammation. This reduction in inflammation corresponded
to improvement in cognitive function as measured by MMSE scores in
this patient with AD.
“We believe these additional data further support our
Treg-focused approach to develop safe and effective treatments for
neurodegenerative diseases of high unmet need. We remain excited
about the outcome of our studies with COYA 301 in AD and COYA 302
in ALS, and look forward to the next steps in progressing these
programs,” Howard H Berman, Ph.D., founder and Chief Executive
Officer of Coya commented.
About Alzheimer’s Disease
Alzheimer's disease is the most common cause of dementia, a
general term for memory loss and other cognitive abilities serious
enough to interfere with daily life. Alzheimer's disease accounts
for up to 80% of dementia cases, affecting an estimated 5.7 million
Americans. In more than 90% of people with Alzheimer’s, symptoms do
not appear until after age 60. The incidence of the disease
increases with age and doubles every 5 years beyond age 65.
Alzheimer's is a progressive disease, where dementia symptoms
gradually worsen over a number of years. In its early stages,
memory loss is mild, but with late-stage Alzheimer's, individuals
lose the ability to carry on a conversation and respond to their
environment. It is the sixth leading cause of death among all
adults and the fifth leading cause for those aged 65 or older. On
average, a person with Alzheimer's lives 4 to 8 years after
diagnosis but can live as long as 20 years, depending on other
factors. 1,2
References
- Alzheimer’s Association (www.alz.org).
- Centers for Disease Control and Prevention (www.cdc.gov).
About Coya Therapeutics, Inc.
Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq:
COYA) is a clinical-stage biotechnology company developing
proprietary treatments focused on the biology and potential
therapeutic advantages of regulatory T cells (“Tregs”) to target
systemic inflammation and neuroinflammation. Dysfunctional Tregs
underlie numerous conditions including neurodegenerative,
metabolic, and autoimmune diseases, and this cellular dysfunction
may lead to a sustained inflammation and oxidative stress resulting
in lack of homeostasis of the immune system. Coya’s investigational
product candidate pipeline leverages multiple therapeutic
modalities aimed at restoring the anti-inflammatory and
immunomodulatory functions of Tregs. Coya’s lead therapeutic
programs includes Treg-enhancing biologics (COYA 300 Series product
candidates) COYA 301 and COYA 302, which are intended to enhance
Treg function and expand Treg numbers. COYA 301 is a cytokine
biologic for subcutaneous administration intended to enhance Treg
function and expand Treg numbers in vivo, and COYA 302 is a
biologic combination for subcutaneous and/or intravenous
administration intended to enhance Treg function while depleting T
effector function and activated macrophages. These two mechanisms
may be additive or synergistic in suppressing inflammation. For
more information about Coya, please visit
www.coyatherapeutics.com.
Forward-Looking Statements
This press release contains “forward-looking” statements that
are based on our management’s beliefs and assumptions and on
information currently available to management. Forward-looking
statements include all statements other than statements of
historical fact contained in this presentation, including
information concerning our current and future financial
performance, business plans and objectives, current and future
clinical and preclinical development activities, timing and success
of our ongoing and planned clinical trials and related data, the
timing of announcements, updates and results of our clinical trials
and related data, our ability to obtain and maintain regulatory
approval, the potential therapeutic benefits and economic value of
our product candidates, competitive position, industry environment
and potential market opportunities. The words “believe,” “may,”
“will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,”
and similar expressions are intended to identify forward-looking
statements.
Forward-looking statements are subject to known and unknown
risks, uncertainties, assumptions and other factors including, but
not limited to, those related to risks associated with the impact
of COVID-19; the success, cost and timing of our product candidate
development activities and ongoing and planned clinical trials; our
plans to develop and commercialize targeted therapeutics; the
progress of patient enrollment and dosing in our preclinical or
clinical trials; the ability of our product candidates to achieve
applicable endpoints in the clinical trials; the safety profile of
our product candidates; the potential for data from our clinical
trials to support a marketing application, as well as the timing of
these events; our ability to obtain funding for our operations;
development and commercialization of our product candidates; the
timing of and our ability to obtain and maintain regulatory
approvals; the rate and degree of market acceptance and clinical
utility of our product candidates; the size and growth potential of
the markets for our product candidates, and our ability to serve
those markets; our commercialization, marketing and manufacturing
capabilities and strategy; future agreements with third parties in
connection with the commercialization of our product candidates;
our expectations regarding our ability to obtain and maintain
intellectual property protection; our dependence on third party
manufacturers; the success of competing therapies or products that
are or may become available; our ability to attract and retain key
scientific or management personnel; our ability to identify
additional product candidates with significant commercial potential
consistent with our commercial objectives; and our estimates
regarding expenses, future revenue, capital requirements and needs
for additional financing.
We have based these forward-looking statements largely on our
current expectations and projections about future events and trends
that we believe may affect our financial condition, results of
operations, business strategy, short-term and long-term business
operations and objectives, and financial needs. Moreover, we
operate in a very competitive and rapidly changing environment, and
new risks may emerge from time to time. It is not possible for our
management to predict all risks, nor can we assess the impact of
all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements
we may make. In light of these risks, uncertainties and
assumptions, the forward-looking events and circumstances discussed
herein may not occur and actual results could differ materially and
adversely from those anticipated or implied in the forward-looking
statements. Although our management believes that the expectations
reflected in our forward-looking statements are reasonable, we
cannot guarantee that the future results, levels of activity,
performance or events and circumstances described in the
forward-looking statements will be achieved or occur. We undertake
no obligation to publicly update any forward-looking statements,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20230607005124/en/
Investor Contact David Snyder
david@coyatherapeutics.com
Hayden IR James Carbonara (646)-755-7412 James@haydenir.com
Media Contact Jessica Starman
media@coyatherapeutics.com
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