This open-label Phase 1 study measures safety,
peripheral and central inflammation, effects on Treg cell
populations, and FTD progression;
Five of the 8 planned FTD subjects have been
enrolled to date;
Results of study will inform Coya’s randomized,
double-blinded Phase 2 trial of COYA 302 in patients with FTD
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics intended to enhance regulatory T cell (Treg) function,
announces that five of eight patients have been enrolled in the
investigator-initiated academic study of LD IL-2 + CTLA4-Ig
combination in patients with Frontotemporal Dementia (FTD). The
study is being conducted by Drs. Stanley Appel and Alireza Faridar
at Houston Methodist Hospital. Topline results of the study will be
leveraged to inform and finalize the planned trial design of a
Company-sponsored, randomized, double-blinded Phase 2 trial of COYA
302 in patients with FTD. Coya has been awarded $5 million by the
Alzheimer’s Drug Discovery Foundation (ADDF) to support the
development of COYA 302 in FTD.
The current investigator-initiated study is evaluating the
effects of LD IL-2 + CTLA4-Ig on a variety of parameters in
patients with FTD, including safety, tolerability, Treg cell
populations, peripheral and central inflammation, and disease
progression. COYA 302 is a proprietary formulation of this biologic
combination therapy, comprised of low dose interleukin-2 (LD IL-2)
and cytotoxic T lymphocyte-associated antigen 4 immunoglobulin
fusion protein (CTLA4-Ig).
Fred Grossman D.O., President and CMO of Coya, stated, “We plan
to submit an IND for FTD, and the data from the
investigator-initiated study will inform some design features of
this planned trial. COYA 302 has potential therapeutic application
in a variety of neurodegenerative diseases, starting with ALS and
FTD.”
Tregs are dysfunctional and compromised in patients with FTD,
skewing the immune system toward a proinflammatory status and
potentially contributing to disease progression. The combination of
LD IL-2 + CTLA4-Ig is believed to have additive and/or synergistic
effects on enhancing Treg cell populations and lowering
peripheral/central inflammation.
Prior data presented by the investigators at the AD/PD 2024
Conference in March 2024 demonstrated that Treg suppressive
function was significantly reduced in patients with FTD, compared
to controls (p<0.01), demonstrating that Treg immunomodulatory
function is negatively impacted in FTD and peripheral levels of
inflammatory cytokines and chemokines are increased, supporting the
critical role of the immune system in the pathophysiology of FTD.
Treg dysfunction and increased levels of inflammatory cytokines and
chemokines have been previously reported by Coya in other serious
and progressive neurodegenerative diseases and support the
multi-pathway combination approach of COYA 302 to target numerous
components of the dysfunctional immune system.
About Frontotemporal Dementia
Frontotemporal dementia (FTD) is the result of damage to neurons
in the frontal and temporal lobes of the brain. Many possible
symptoms can result, including unusual behaviors, emotional
problems, trouble communicating, difficulty with work, or
difficulty with walking. FTD is rare and tends to occur at a
younger age than other forms of dementia. About 60% of people with
FTD are 45 to 64 years old. FTD is progressive, meaning symptoms
get worse over time. In the early stages, people may have just one
symptom. As the disease progresses, other symptoms appear as more
parts of the brain are affected. It is difficult to predict how
long someone with FTD will live. Some people live more than 10
years after diagnosis, while others live less than two years after
they are diagnosed. There is no cure for FTD, and no treatments
slow or stop the progression of the disease.1
References
- Atassi N, et al. The PRO-ACT database: design, initial
analyses, and predictive features. Neurology,
2014;83:1719–1725.
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, and Parkinson’s
Diseases (PD). 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 CTLA-4 Ig in a small cohort of patients with
ALS conducted at the Houston Methodist Research Institute (Houston,
Texas). This study was the first-of-its-kind evaluating 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 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 ALSFRS-R scores at week
24 and week 48 after initiation of treatment were not statistically
different compared to the ALSFRS-R score at baseline, suggesting
that disease progression was ameliorated over the 48-week treatment
period. Treg suppressive function, expressed as 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.
The study also evaluated serum biomarkers of inflammation,
oxidative stress, and lipid peroxides. The available data up to 16
weeks after initiation of treatment suggested 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.
COYA 302 – the Company’s lead biologic investigational product,
or “Pipeline in a Product,” is a proprietary combination therapy
consisting of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig
for subcutaneous administration with a unique dual mechanism of
action that is now being developed for the treatment of Amyotrophic
Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease,
and Alzheimer’s Disease. Its multi-targeted approach is designed to
enhance the number and anti-inflammatory function of Tregs and
simultaneously lower the expression of activated microglia and the
secretion of pro-inflammatory mediators. This synergistic mechanism
may lead to the re-establishment of immune balance and amelioration
of inflammation in a sustained and durable manner that may not be
achieved by either low-dose IL-2 or CTLA4-Ig alone.
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/20241218222722/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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