- The double-blind, placebo-controlled study (funded by the Gates
Foundation and Alzheimer’s Association) evaluates the safety and
tolerability, biological activity, biomarkers, neuroimaging, and
preliminary efficacy of LD IL-2 in 38 patients with
mild-to-moderate AD over 30 weeks;
- Previously reported data from an open-label, proof-of-concept
study in 8 AD patients illustrated that treatment with LD IL-2
resulted in a statistically significant improvement in cognitive
function, as measured by the Mini-Mental State Examination test
(MMSE) and no cognitive decline was observed as measured by the AD
Assessment Scale–Cognitive Subscale (ADAS-Cog), and the Clinical
Dementia Rating-Sum of Boxes scale (CDR-SB);
- Dr. Guillaume Dorothée, Ph.D., Member of Coya’s Scientific
Advisory Board, was among the first to illustrate the role of
Regulatory T cells (Tregs) in AD and the therapeutic effects of LD
IL-2 in modifying AD pathology and restoring cognitive function in
animal models of AD;
- Coya’s proprietary investigational LD IL-2 (COYA 301) for
subcutaneous administration has been designed to enhance the
function of Tregs in vivo and is being developed as a monotherapy
for the treatment of AD and in combination with CTLA4 Ig (COYA 302)
for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
multiple therapeutic platforms intended to enhance Treg function,
including biologics and cell therapies, today announced completion
of enrollment in a randomized, double-blind, placebo-controlled
phase 2 study of LD IL-2 in patients with mild-to-moderate AD. The
study is being conducted by Drs. Stanley Appel and Alireza Faridar
at the Houston Methodist Hospital.
A total of 38 patients were randomly assigned to receive
subcutaneous LD IL-2 at two different dosing regimens, or matching
placebo, over 21 weeks. The first patient cohort was randomized to
receive LD IL-2 for 5 consecutive days every 4 weeks and the second
cohort was randomized to receive LD IL-2 for 5 consecutive days
every 2 weeks.
This phase 2 well-controlled study will evaluate the safety and
tolerability, biological activity, blood and cerebrospinal fluid
biomarkers, neuroimaging, and changes in cognitive function of LD
IL-2 compared to placebo at pre-specified timepoints over the
course of the 21-week treatment period and at 9 weeks after the
last dose of study treatment.
Topline results of the study are anticipated to be reported in
Summer 2024. The study is funded by the Gates Foundation and the
Alzheimer’s Association.
Coya previously reported that the treatment with LD IL-2
significantly expanded Treg population and function in an
open-label proof-of concept study in 8 patients with AD. At
baseline, the mean (SD) percentage of Tregs was 4.55 (1.97) and was
almost double at the end of the treatment [8.68 (2.99), p=0.0004].
Mean (SD) Treg suppressive function was 46.61% (7.74) at baseline,
and significantly increased to 79.5 % (20.55) at the end of
treatment (p=0.003). In addition, evaluation of cognitive function
showed that administration of LD IL-2 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 LD IL-2, compared to pre-treatment baseline
scores, indicating no cognitive decline as measured by these
validated instruments. Overall, administration of LD IL-2 appeared
to be well tolerated in the 8 patients in the open-label, proof-of
concept study. The most common adverse events were mild
injection-site reactions and mild leukopenia. No serious adverse
events were reported, and no patient discontinued the study.
Howard Berman, Ph.D., CEO of Coya Therapeutics, stated, “We
believe that a positive efficacy signal in this well powered AD
trial will support advancing development of this potential therapy
in Alzheimer's Disease and will lead to further study as
monotherapy and in combination with recently approved
treatments.”
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 therapeutic platforms
include Treg-enhancing biologics, Treg-derived exosomes, and
autologous Treg cell therapy. Coya’s 300 Series product candidates,
COYA 301 and COYA 302, are biologic therapies 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/20231009522751/en/
Investor Contact David Snyder
david@coyatherapeutics.com
Hayden IR James Carbonara 646-755-7412
James@haydenir.com
Media Contact Anna Marie Imbordino
annamarie@quantum-corp.com 917-680-8765
Coya Therapeutics (NASDAQ:COYA)
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