- Coya has a clear path towards submission of the IND application
to the FDA in the second quarter of 2024, with a planned initiation
of a well-controlled, double-blind clinical trial of COYA 302 in
patients with ALS upon acceptance of the IND
Coya Therapeutics, Inc. (“Coya”), a clinical-stage biotechnology
company today announced successful meetings with the U.S. Food and
Drug Administration (FDA) following a pre-IND (Investigational New
Drug) meeting and a Type C meeting intended to seek advice from the
Agency to reach alignment on multiple aspects of the planned
development program in support of an IND application of COYA 302
for the treatment of ALS.
COYA 302 is a dual-mechanism investigational biologic
combination therapy comprised of proprietary low dose IL-2 and
fusion protein CTLA-4 Ig. Low dose IL-2 enhances anti-inflammatory
Treg function and numbers while the fusion protein CTLA-4 Ig is
intended to suppress pro-inflammatory cell function enabling
potentially synergistic mechanisms in modulating inflammatory
pathways.
As a result of the interactions with the FDA, Coya has obtained
constructive feedback and has reached alignment on key areas
involved in the development of COYA 302, including CMC (chemistry,
manufacturing, and controls), preclinical and clinical activities
for the IND application. The results of the regulatory meetings
constitute a significant step towards the submission of the IND
application to the FDA in the second quarter of 2024, and
initiation of a well-controlled, double-blind clinical trial of
COYA 302 in patients with ALS upon acceptance of the IND. Coya
plans to continue working closely with the FDA over the course of
the COYA 302 development program.
Dr. Fred Grossman, President and Chief Medical Officer of Coya
stated, “This important feedback allows us to advance our
development program in ALS with a planned double-blind controlled
study, with the potential for bringing forward a much-needed
therapy for ALS patients.”
Howard H. Berman, Ph.D., CEO of Coya stated: “We believe that
gaining alignment with FDA through multiple regulatory meetings on
the path to filing an IND in Q2, 2024 is an important next step in
advancing the program in patients with ALS. With the recent
out-licensing transaction and private placement transaction
securing Coya a cash runway into 2026 and through completion of
this study, we believe that we are in a position to execute and
deliver value to patients and shareholders.”
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 CTLA-4 Ig and is
being developed for subcutaneous administration for the treatment
of patients with ALS. 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 LD IL-2 and
CTLA-4 Ig in 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 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 (±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 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 of 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 Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's
Disease, is a rare neurological disease that affects motor neurons,
the nerve cells in the brain and spinal cord that control voluntary
muscle movement. About 20,000 people live with ALS in the United
States and approximately 5,000 new cases are diagnosed every year.
The disease is progressive, meaning the symptoms get worse over
time. The functional status of ALS patents declines about 1 point
per month on average, as measured by the Revised ALS Function
Rating Scale1, or ALSFRS-R, a validated tool to monitor the
progression of the disease. ALS has no cure, and the currently
approved drug treatments provide limited benefit to patients. ALS
is a type of motor neuron disease. As motor neurons degenerate and
die, they stop sending messages to the muscles, which causes the
muscles to weaken, start to twitch (fasciculations), and waste away
(atrophy). Eventually, the brain loses its ability to initiate and
control voluntary movements. Most people with ALS die from
respiratory failure, usually within three to five years from when
the symptoms first appear.2
- Atassi N, et al. The PRO-ACT database: design, initial
analyses, and predictive features. Neurology, 2014;83:1719–1725.
doi: 10.1212/WNL.0000000000000951.
- National Institutes of Health (NIH) Website
(https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als),
accessed on January 4, 2023.
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’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/20240105424614/en/
Investor Contact David Snyder
david@coyatherapeutics.com
Hayden IR James Carbonara James@haydenir.com
646-755-7412
Media Contact Jessica Starman
media@coyatherapeutics.com
Coya Therapeutics (NASDAQ:COYA)
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