Coya Therapeutics Announces That Its Combination LD IL-2/GLP-1 RA Candidate (COYA 303) Demonstrated Potent Systemic and Brain Anti-Inflammatory Efficacy In Vivo

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11/04/2025 - 08:00 AM

COYA 303 is an investigational proprietary biologic combination of low-dose (LD)-IL-2 and GLP-1 receptor agonist (RA) for subcutaneous administration with potential for treating inflammation-driven diseases like Alzheimer's Disease, and other neurodegenerative and autoimmune diseases

COYA 303 significantly reduced peripheral pro-inflammatory cell expansion, enhanced Regulatory T Cell function, attenuated CNS inflammation, and shifted macrophages to an anti-inflammatory phenotype, compared to controls

COYA-303 may represent a next-generation dual immunomodulatory GLP-1–based therapy uniting the Nobel Prize–recognized science of regulatory T cells (Tregs) with the emerging immune benefits of GLP-1 receptor agonists.

HOUSTON--(BUSINESS WIRE)-- 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 an in vivo animal study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA investigational proprietary biologic combination) in a well-characterized in vivo lipopolysaccharide (LPS) preclinical mouse model of systemic and neurologic inflammation. Results from this completed study confirmed the interim findings previously reported by the Company.

Representative Data for Systemic Tregs and Immunomodulation Credit: Coya Therapeutics, Inc.

Dr. Fred Grossman, Coya’s Chief Medical Officer, stated, “This study strengthens our multi-targeted approach developing new therapies for diseases of high unmet need. COYA 303 has shown synergistic effects reducing peripheral and central inflammation in vitro and in vivo. We believe this supports our combination approach with potential development in neurodegenerative diseases.”

Dr. Arun Swaminathan, Coya’s CEO, stated, “We believe the data supports the potential of COYA-303 to improve the efficacy of GLP-1 RA in neurodegenerative diseases like Alzheimer's Disease in a synergistic manner. The anticipated readout of the Novo Nordisk EVOKE and EVOKE+ trials studying semaglutide, a GLP-1 RA in patients with mild Alzheimer’s Disease will inform our strategy moving forward.”

Study Highlights:

In this animal model, mice received daily injections of LPS for five days to induce a moderate but sustained inflammatory response representative of chronic inflammation seen in neurodegenerative disease. Animals were treated with daily injections of COYA 303 for four days, starting a day after initiation of LPS injections. The study control groups included the individual components of COYA 303, vehicle-only, and LPS-only treated animals.

Coya intends to publish a full dataset which the Company believes demonstrates that COYA 303 significantly modulates multiple systemic and central nervous system immune parameters and shifts monocytes from a pro-inflammatory to an anti-inflammatory phenotype. Moreover, the Company believes COYA 303 has significant effects on multiple Treg-associated activation and functional markers, indicating enhanced Treg stability and suppressive capacity.

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. 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

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