- The open-label study evaluated the safety and tolerability,
biological activity, blood biomarkers and preliminary efficacy of
low-dose interleukin 2 (ld IL-2) in 8 patients with Alzheimer’s
disease (AD). The academic study was conducted by Dr. Appel and Dr.
Faridar at the Houston Methodist Hospital.
- The additional clinical data show a significant decrease in
biomarker levels known to be associated with neuroinflammation in
AD patients further supporting the initial positive results of the
study. Blood levels of CCL4 (CC motif chemokine ligand 4), FLT3LG
(FMS-related tyrosine kinase 3 ligand) and TNFα (tumor necrosis
factor alpha) were consistently lower following administration of
ld IL-2.
- Coya’s investigational ld IL-2 for subcutaneous administration
has been designed to enhance the function of regulatory T cells
(Tregs) in vivo and it is being developed for the treatment of
neurodegenerative and autoimmune diseases, as monotherapy or in
combination with other immunomodulatory agents.
- Previously released data showed 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). In addition, no cognitive decline was observed when it was
measured by the Alzheimer’s Disease Assessment Scale–Cognitive
Subscale (ADAS-Cog), and the Clinical Dementia Rating-Sum of Boxes
scale (CDR-SB).
- Over the course of the study, ld IL-2 demonstrated biological
activity by restoring peripheral Treg function and numbers and
significantly lowering the blood levels of other well-characterized
proinflammatory cytokines and chemokines, such as IL-15
(interleukin 15), CCL2 (monocyte chemoattractant protein-1) and
CCL11 (CC motif chemokine ligand 11).
- Treatment with ld IL-2 administered subcutaneously appeared to
be safe and well tolerated in patients with AD.
- An ongoing phase 2, double blind, placebo controlled trial
(funded by the Gates foundation and Alzheimer’s Association) in
approximately 46 patients with mild to moderate AD is almost fully
enrolled and should report top line results in July, 2024.
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 reported results from
an open-label proof-of-concept clinical study for ld IL-2 in
patients with AD. Results of the study were presented July 16,
2023, at the Alzheimer’s Association International Conference
(AAIC) in Amsterdam, Netherlands. The poster can be accessed
here.
The 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 subcutaneous ld IL-2
for four monthly cycles and were followed for two months
post-treatment. Treg function and numbers, serum biomarkers of
inflammation, safety and tolerability, and cognitive functioning as
measured by the ADAS-Cog, CDR-SB and MMSE assessment tools were
evaluated.
The additional blood biomarker data showing a significant
decrease in the blood levels of the proinflammatory cytokines and
chemokines CCL4, FLT3LG and TNFα in AD patients treated with ld
IL-2 strengthen the positive results Coya has previously announced
in May 2023.
Coya previously reported that the treatment with ld IL-2
significantly expanded Treg population and function. 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 COYA 301, 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 safe and well
tolerated. 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.
Following the encouraging results of this open-label
proof-of-concept study, a Phase 2 double-blind, placebo-controlled
study in approximately 46 patients with mild-to-moderate AD is
being conducted at the Houston Methodist Hospital and as of today,
is almost fully enrolled with 38 patients in the study. The
well-controlled clinical study will evaluate the safety and
tolerability, Teg function, blood biomarkers of neuroinflammation,
and efficacy of two dose regimens of ld IL-2 compared to placebo,
over a 30-week period. Top-line results are anticipated in July
2024. The study is funded by the Gates Foundation and the
Alzheimer’s Association.
Stanley Appel, M.D., Professor at Houston Methodist and Chair of
Coya’s Scientific Advisory Board commented, “Our research studies
documenting a significant reduction of Treg neuroprotective
functions in AD led to our use of low dose IL-2 to enhance Treg
numbers and suppressive functions. Our 8 patient study in AD was
safe and well tolerated, decreased pro-inflammatory signaling, and
suggested a beneficial clinical effect. We are optimistic that this
approach, now being tested in a larger double-blind
placebo-controlled study, may help address the unmet needs of our
deserving AD patients.”
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/20230717586626/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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