Investigator-initiated data from Houston
Methodist Hospital showed LD IL-2 reduced proinflammatory factors,
both systemically and within the central nervous system, while
demonstrating statistically significant improvement in beta amyloid
42 clearance with stabilization of cognitive decline over a
five-month treatment period
Comprehensive data set will be presented and
released throughout 2025 and in a peer reviewed publication
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics intended to enhance regulatory T cell (Treg) function,
announced encouraging blood biomarker data from an
investigator-initiated, 21-week, double-blind, placebo-controlled,
exploratory Phase 2 study of LD IL-2 in patients with Alzheimer’s
disease (AD).
Statistically significant reduced levels of proinflammatory
markers were observed in patients receiving a five-day treatment of
subcutaneous LD IL-2 on a monthly cycle in comparison to a biweekly
5-day administration or placebo. Lower blood levels of the
proinflammatory chemokine (C-C motif) ligand 2 (CCL2) (p<0.05)
and proinflammatory cytokine IL-15 (p <0.001) were statistically
significant, and a statistically significant increase in the
anti-inflammatory cytokine IL-4 (p<0.01) in patients receiving
monthly cycles of LD IL-2 was observed, compared to patients
receiving placebo. At the end of the five-month treatment period
when treatment was removed, the anti-inflammatory benefits reverted
back to placebo levels. In addition, patients receiving LD IL-2
cycles at the higher biweekly frequency showed a smaller impact on
these factors compared to monthly LD IL-2, supporting the potential
beneficial effects of monthly LD IL-2.
"We believe the reduction of proinflammatory factors within
peripheral blood corresponding with significant improvement in beta
amyloid 42 in the cerebrospinal fluid and cognitive stabilization
during LD IL-2 therapy underscores the importance of targeting
regulatory T cells in Alzheimer’s disease. We believe LD IL-2
offers an immunomodulatory strategy that enhances Treg function for
potentially treating Alzheimer’s disease and several other
neurodegenerative disorders,” commented Coya CMO Fred Grossman,
DO.
The statistically significant improvement in serum inflammatory
markers corresponded with previously-reported findings from AD
patients receiving monthly LD IL-2 compared to patients receiving
biweekly LD IL-2 or placebo. Monthly LD IL-2 showed an increase in
Aβ42 levels in cerebrospinal fluid (CSF), suggesting increased
clearance of amyloid-β, stable levels of neurofilament light chain
(NfL) in CSF, and statistically significant Treg expansion, all
demonstrating targeted biological activity. In addition, patients
receiving monthly LD IL-2 showed a 4.93-point improvement in the
ADAS-Cog score compared to placebo over the 21-week treatment
period.
Topline results from this investigator-initiated study were
presented in October 2024 at the Clinical Trials on Alzheimer’s
Disease Conference (CTAD) in Madrid. The main objectives of the
study were to evaluate safety and tolerability, biological
activity, and preliminary efficacy of LD IL-2 administered at two
different dosing regimens. This academic study was conducted at the
Houston Methodist Research Institute and received funding from the
Alzheimer's Association, the Gates Foundation, and the National
Institute on Aging, with additional support from Coya.
LD IL-2 was well-tolerated and no serious adverse events (SAEs)
or deaths were reported. The most common AEs were mild injection
site reactions and a mild increase in eosinophil counts.
LD IL-2 plays a key role in the expansion and immunomodulatory
function of Tregs in vivo. LD IL-2 binds to the high affinity
interleukin-2 receptor α-chain (IL-2Rα; CD25), which is mainly
expressed in Tregs. In contrast, higher doses of IL-2 also bind to
the lower affinity IL-2Rβ (CD122), which stimulates proinflammatory
T cells and NK cells. The improved biological and clinical effects
experienced by patients receiving monthly LD IL-2 administration
could be due to selective expansion of Tregs at lower doses, while
higher IL-2 doses activate pro-inflammatory pathways.
Coya plans to publish and present the results of this study
throughout 2025.
Coya CEO Arun Swaminathan, Ph.D., added, "While monotherapy with
LD IL-2 shows targeted improvement in biological activity in
patients with AD, as demonstrated in this early Phase 2 academic
study, we think that combining our proprietary LD IL-2 (COYA 301)
with several other immunomodulatory modalities could deliver
additive or even synergistic targeted effects."
Summary of Study Design
The investigator-initiated, randomized, double-blind,
placebo-controlled Phase 2 trial evaluated two dosing regimens of
subcutaneous LD IL-2 in 38 participants with Alzheimer’s disease
that were between the ages of 50 to 86 and had Mini-Mental State
Examination (MMSE) scores ranging from 12 to 26.
Of the 38 total participants, 22 were randomized in a 1:1 ratio
to receive either five days of LD IL-2 (106 IU/day) (LD IL-2 q4wks)
or placebo every four weeks for 21 weeks. An additional 16
participants were randomized in a 2:1 ratio to receive 5-day cycles
of LD IL-2 every two weeks (LD IL-2 q2wks) or placebo for the same
21-week duration. All participants were monitored for nine weeks
post-treatment, resulting in a total study period of 30 weeks.
Demographics and baseline disease characteristics were comparable
among the treatment groups.
The primary endpoint was the incidence and severity of adverse
events (AEs), with the secondary endpoint evaluating changes in
Tregs. Exploratory endpoints assessed changes in cerebrospinal
fluid (CSF), AD-related biomarkers, and cognitive status.
About COYA 301
COYA 301 is the company’s proprietary investigational low-dose
interleukin-2 (IL-2) intended to enhance the anti-inflammatory
function of regulatory T cells (Tregs) and is designed for
subcutaneous administration. COYA 301 is an investigational product
not yet approved by the FDA or any other regulatory agency.
About COYA 302
COYA 302 is an investigational and proprietary biologic
combination therapy with a dual immunomodulatory mechanism of
action intended to enhance the anti-inflammatory function of
regulatory T cells (Tregs) and suppress the inflammation produced
by activated monocytes and macrophages. COYA 302 is comprised of
proprietary low-dose interleukin-2 (LD IL-2) and cytotoxic T
lymphocyte-associated antigen 4 immunoglobulin fusion protein
(CTLA4-Ig) and is being developed for subcutaneous administration
for the treatment of patients with ALS, FTD, Parkinson’s Diseases
(PD), and Alzheimer’s disease. These mechanisms may have additive
or synergistic effects.
In February of 2023, Coya announced results from a
proof-of-concept, open-label clinical study evaluating commercially
available LD IL-2 and CTLA4-Ig in a small cohort of patients with
ALS conducted at the Houston Methodist Research Institute (Houston,
Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and
David Beers, Ph.D. This study was the first-of-its-kind to evaluate
this dual-mechanism immunotherapy for the treatment of ALS.
Patients in the study received investigational treatment for 48
consecutive weeks and were evaluated for safety and tolerability,
Treg function, serum biomarkers of oxidative stress and
inflammation, and clinical functioning as measured by the Revised
Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R)
scale.
During the 48-week treatment period, the therapy was well
tolerated. The most common adverse event was mild injection-site
reactions. No patient discontinued the study, and no deaths or
other serious adverse events were reported.
Patients' disease progression was measured using the ALSFRS-R
scale, a validated rating tool for monitoring the progression of
disability in patients with ALS. The mean (±SD) ALSFRS-R scores at
week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of
treatment were not statistically different compared to the ALSFRS-R
score at baseline (33.5 ±5.9), suggesting significant amelioration
in the progression of the disease over the 48-week treatment
period.
Treg suppressive function, expressed as a percentage of
inhibition of proinflammatory T cell proliferation, showed a
statistically significant increase over the course of the treatment
period and was significantly reduced at the end of the 8-week
washout post-treatment period. Treg suppressive function at 24
weeks (79.9 ±9.6) and 48 weeks (89.5 ±4.1) were significantly
higher compared to baseline (62.1 ±8.1) (p<0.01), suggesting
enhanced and durable Treg suppressive function over the course of
treatment. In contrast, Treg suppressive function (mean ±SD) was
significantly decreased at the end of the 8-week washout period
compared to end-of-treatment at week 48 (70.3±8.1 vs. 89.5±4.1, p
<0.05).
The study also evaluated serum biomarkers of inflammation,
oxidative stress, and lipid peroxides. The available data up to 16
weeks after initiation of treatment suggest a decrease in these
biomarker levels, which is consistent with the observed enhancement
of Treg function. The evaluation of the full biomarker data is
ongoing.
COYA 302 is an investigational product not yet approved by the
FDA or any other regulatory agency.
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 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.
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 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/20250206168584/en/
Investor Contact David
Snyder, CFO david@coyatherapeutics.com
CORE IR Bret Shapiro brets@coreir.com 561-479-8566
Media Contacts For Coya
Therapeutics: Kati Waldenburg media@coyatherapeutics.com
212-655-0924
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