Data demonstrates halting of disease progression in patients
with Amyotrophic Lateral Sclerosis (ALS) at 24 weeks (6 months) and
a consistent reduction in inflammation, oxidative stress, and
enhanced Regulatory T cell (Treg) number and suppressive function
in patients who were administered a combination of CTLA4-Ig Fusion
Protein (CTLA4-Ig) and Low Dose Interleukin-2 (LD IL-2);
Prior to initiating treatment, patients were declining at an
average rate of -1.1 points per month on the ALSFRS-R rating scale-
At the end of 6 months of treatment, the mean rate of change on the
ALSFRS-R was +0.04 points per month.
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologic intended to enhance regulatory T cell (Treg) function,
announces the publication of a peer-reviewed manuscript titled,
“A Phase 1 Proof-of-Concept Study Evaluating Safety,
Tolerability, and Biological Marker Responses with Combination
Therapy of CTLA4-Ig and Interleukin-2 in Amyotrophic Lateral
Sclerosis,” in the medical journal Frontiers in Neurology. The
publication can be viewed here.
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the full release here:
https://www.businesswire.com/news/home/20240611572383/en/
Disease progression remained relatively
unchanged during the first 6 months of CTLA4-Ig/LD IL-2 treatment
(Graphic: Business Wire)
Dr. Stanley Appel, MD, Edwards Distinguished Endowed Chair for
ALS and Director, Johnson Center for Cellular Therapeutics at
Houston Methodist stated, “The ability of the combination therapy
to halt clinical progression in ALS for 24 weeks provides an
important proof of concept for the protective role of Tregs while
simultaneously suppressing inflammation. What is most gratifying is
the concomitant reduction of the lipid peroxide 4-HNE as well as
inflammatory cytokines. This study provides the basis for a
large-scale double-blind placebo-controlled trial to establish
potential therapeutic efficacy for ALS patients.”
Dr. Howard H. Berman, CEO of Coya Therapeutics, stated: “This
publication illustrates a promising clinical signal of a novel
biologic combination immunotherapy in ALS, a truly devastating
condition with high unmet need. Our development of our ALS program
continues, and Coya remains on track to file its Investigational
New Drug Application (IND) with the Food and Drug Administration
(FDA) for its proposed randomized double blind placebo controlled
study for LD IL-2 + CTLA4-Ig in ALS this month (June, 2024).
Concurrently, our strong balance sheet ensures that we have
adequate capital to execute on this upcoming study.”
In this open-label study, four participants with ALS received
subcutaneous injections of commercial LD IL-2 (1x106
IU/injection/day) for 5 consecutive days every 2 weeks and one
subcutaneous injection of CTLA4-Ig (125 mg/mL/injection) every 2
weeks for a total of 24 treatment cycles during the 48-week
treatment period. Study participants were followed for additional 8
weeks after treatment with LD IL-2 / CTLA4-Ig. Three participants
were sporadic ALS while 1 participant (#1) had mutant
C9ORF72-mediated ALS, and 3 participants had respiratory
insufficiency according to a qualifying low maximal inspiratory
pressure (MIP) value (≤ 60 cm H2O), 2 of which were already being
treated with noninvasive ventilation. Prior to initiating
treatment, patients had a documented average disease progression of
-1.1 points per month in the ALSFRS-R score.
Summary of Results:
Safety and tolerability of CTLA4-Ig/LD IL-2 treatment:
Treatment was well tolerated among all patients. There were no
serious adverse events and only mild treatment emergent adverse
events, and all patients completed the study.
Treg Suppressive Function: Treg suppressive function was
significantly increased compared to baseline at weeks 16, 24 and 48
and returned to baseline levels at 6 weeks after the final course
of treatment (washout)
Clinical Progression: For all 4 participants, the mean
rate of change in the ALSFRS-R over the first 24 weeks was stable
(+0.04 points/month). During this time period, the ALSFRS-R
improved by 4 points in participant #1, improved by 3 points in
participant #2, was unchanged in participant #3, and decreased by 6
points in participant #4. Participant #4 experienced a 4-point
decrease at week 4, but then remained relatively stable from weeks
4 to 24. Over the 48-week treatment period, the average rate of
change in the ALSFRS-R was -0.13 points/month.
Biological Marker Changes: Biological markers of
oxidative stress (4-HNE and ox-LDL), inflammation (IL-18), and
structural degeneration (Nf-L) were assessed at baseline and
throughout the course of the study. During the first 16 weeks of
treatment, 3 participants showed a decreasing trend of 4-HNE, all 4
participants showed decreasing trend of ox-LDL, 3 participants
showed a decreasing trend of IL-18, and 2 participants showed
decreasing trend in Nf-L. These trends corresponded with the
participants lack of observable disease progression during this
time.
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 CTLA4-Ig and is
being developed for subcutaneous administration for the treatment
of patients with ALS, FTD, and 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 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 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 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 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 patients 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
References
- 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), accessed on January 8,
2024.
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 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 enhances the number and
anti-inflammatory function of Tregs and simultaneously lowers 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/20240611572383/en/
Investor Contact David
Snyder, CFO david@coyatherapeutics.com
CORE IR Bret Shapiro brets@coreir.com 561-479-8566 Media Contacts Kati Waldenburg media@coyatherapeutics.com 212-655-0924
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