Coya Therapeutics' COYA 303 Shows Promising Central Nervous System (CNS) Anti-inflammatory Effects and Systemic Regulatory T Cell (Treg) Enhancing Effects in a Preclinical Animal Inflammation Model

Rhea-AI Summary

Coya Therapeutics (NASDAQ:COYA) reported promising preclinical results for COYA 303, its investigational combination therapy of LD-IL-2 and GLP-1RA, in a mouse model of systemic and neuroinflammation. The study demonstrated significant anti-inflammatory effects both systemically and in the central nervous system.

The first cohort results showed that COYA 303 effectively reduced pro-inflammatory myeloid cells, increased anti-inflammatory immune cells, and attenuated neuroinflammation in the brain. The therapy showed particular promise in enhancing regulatory T cell (Treg) function and survival in inflammatory environments, supporting its potential application in treating Alzheimer's Disease and other neurodegenerative conditions.

The company is currently conducting additional cohort studies to evaluate modified treatment protocols, with plans to present complete findings in a peer-reviewed forum.

Positive

• Significant reduction in pro-inflammatory myeloid cells and associated cytokines
• Demonstrated enhancement of Treg numbers and suppressive function
• Showed effective attenuation of neuroinflammation in cortex and hippocampus brain regions
• Confirmed previous positive findings from in vitro studies

Negative

• Results are only from first cohort of preclinical animal studies
• Additional cohorts still pending completion
• Early-stage research requiring further validation in human trials

Insights

Neuroscience and Immunology Specialist

COYA 303 shows promising anti-inflammatory effects in preclinical studies, supporting its potential for Alzheimer's treatment through a novel dual-mechanism approach.

Coya Therapeutics has reported encouraging preclinical data for COYA 303, their investigational combination therapy of low-dose IL-2 and a GLP-1 receptor agonist. The results from the first cohort in a lipopolysaccharide (LPS) mouse model demonstrate significant dual-action effects on both systemic inflammation and neuroinflammation – two critical pathological processes in Alzheimer's disease progression.

What makes this approach particularly interesting is the mechanistic synergy between the two components. Low-dose IL-2 preferentially activates regulatory T cells (Tregs) through the IL-2 receptor alpha, while GLP-1 receptor agonists modulate myeloid cell function. Both cell types are critical immune regulators that become dysregulated in neurodegenerative diseases. The preclinical data confirms three key effects: enhanced Treg numbers and function, reduced peripheral activated myeloid cells, and attenuated neuroinflammation specifically in the cortex and hippocampus – brain regions critically affected in Alzheimer's disease.

The timing of this announcement is strategically significant, as it positions COYA 303 within the growing interest in GLP-1 receptor agonists for neurodegenerative conditions. With an upcoming semaglutide readout in Alzheimer's Disease generating industry attention, Coya's approach differentiates itself by combining GLP-1 receptor targeting with Treg enhancement, potentially offering superior anti-inflammatory effects compared to GLP-1 monotherapy.

While these results represent only the first cohort of a preclinical study, they provide mechanistic validation for Coya's therapeutic hypothesis. The company is conducting additional cohorts to optimize treatment timing relative to inflammation onset, suggesting they're methodically building evidence to support clinical development. The commitment to peer-reviewed publication adds scientific credibility to their approach.

COYA 303 is an investigational proprietary combination of LD-IL-2 and GLP-1RA for subcutaneous administration, under development for the treatment of diseases, including Alzheimer's Disease, driven by chronic and sustained inflammation;

COYA 303 demonstrated significant attenuation of neuroinflammation in cortex and hippocampus brain regions and upregulation of anti-inflammatory markers, and significant improvement of systemic Treg function and pro-inflammatory cytokines;

Results from the first cohort of this in-vivo animal study confirm the previously reported positive findings from in vitro human immune cell systems demonstrating that COYA 303 significantly enhances Treg suppressive function and survival in highly inflammatory microenvironments.

HOUSTON, Sept. 16, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, today announced results of a study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA), Coya's investigational biologic combination in an established in vivo lipopolysaccharide (LPS) mouse model of systemic and neuroinflammation. Results from the first animal cohort treated with COYA 303 demonstrated broad systemic and central immunomodulatory activity, including significant reductions in LPS-induced pro-inflammatory myeloid cells and associated cytokines, increases in anti-inflammatory immune cell subsets, and attenuation of neuroinflammation in the brain, compared to untreated animals.

The Company believes these findings illustrate the potential of COYA 303 to modulate the inflammatory pathways implicated in Alzheimer's Disease progression and support the continued development of COYA 303 in neurodegenerative conditions where persistent inflammation is a central driver of pathology.

Experimental cohorts 2 and 3 are underway and are designed to assess modified treatment protocols, specifically evaluating the impact of treatment initiation timing relative to the onset of inflammation. Upon completion of the full data set, Coya intends to present and/or publish the findings in a peer-reviewed forum.

Dr. Arun Swaminathan, Coya's Chief Executive Officer, stated "We are encouraged by the positive signal in Cohort 1. These data are particularly timely given the increasing recognition of GLP-1 receptor agonists as potential therapies beyond metabolic disease. The upcoming semaglutide readout in Alzheimer's Disease has generated strong interest, and we believe our unique approach of  combining LD IL-2 with a GLP-1RA in COYA 303 may leverage both Treg enhancement and myeloid modulation to address the systemic and neuroinflammatory drivers of neurodegeneration."

LD IL-2 preferentially binds the IL-2 receptor alpha which is highly expressed on Tregs and plays a key role in enhancing Tregs' anti-inflammatory function. Treg dysfunction is implicated in autoimmune and neurodegenerative diseases characterized by persistent inflammation. GLP-1 receptor agonists (GLP-1RAs) also module immune responses, with both myeloid cells and Tregs expressing a high density of GLP-1 receptors. Our prior in vitro studies showed that combining LD IL-2 with a GLP-1RA synergistically enhances Treg numbers and function and reduces pro-inflammatory activity. The Company believes COYA 303 builds on these findings in a validated in vivo model, potentially delivering synergistic and durable anti-inflammatory effects. Highlights from Cohort 1:

• COYA 303 produced significant systemic and CNS immunomodulatory effects in the LPS model of inflammation
• COYA 303 significantly (a) enhanced Treg numbers and suppressive function, (b) reduced peripheral activated myeloid cells and (c) attenuated neuroinflammation in the cortex and hippocampus

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.

Investor Contact 
David Snyder, CFO
david@coyatherapeutics.com

astr partners
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917-415-1750

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646-942-5595

 

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SOURCE Coya Therapeutics, Inc.

FAQ

What are the key findings of COYA 303 in the preclinical inflammation model?

COYA 303 demonstrated significant anti-inflammatory effects both systemically and in the CNS, including enhanced Treg function, reduced pro-inflammatory myeloid cells, and attenuated neuroinflammation in the cortex and hippocampus.

How does COYA 303 work in treating inflammation?

COYA 303 combines LD IL-2 and GLP-1RA to enhance regulatory T cell (Treg) function and modulate immune responses, targeting both systemic and neuroinflammatory pathways.

What is the potential application of COYA 303 in Alzheimer's Disease?

COYA 303 shows promise in treating Alzheimer's Disease by modulating inflammatory pathways implicated in disease progression through its dual action on Treg enhancement and myeloid modulation.

What are the next steps for COYA 303's development?

Coya Therapeutics is currently conducting experimental cohorts 2 and 3 to assess modified treatment protocols, and plans to present the complete findings in a peer-reviewed forum.

How does COYA's approach differ from other GLP-1 treatments?

COYA 303 uniquely combines LD IL-2 with GLP-1RA, potentially offering synergistic benefits through both Treg enhancement and myeloid modulation, compared to standalone GLP-1 receptor agonists.