Study results demonstrate significant reduction in regulatory T cell (Treg) function and significant increase in circulating pro-inflammatory cytokines and chemokines in patients with FTD

Low-dose IL-2 plus CTLA-4 Ig has previously demonstrated restoration of regulatory T-cell function together with reduction of inflammatory cytokines and monocyte activation in treated patients

Findings of this biomarker study are consistent with previously reported results of an Investigator-Initiated-Trial of LD IL-2 and CTLA-4 Ig in patients with FTD

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, announces the publication of a research study led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute, demonstrating the involvement of the peripheral immune system in the neuroinflammatory profile of frontotemporal dementia (FTD). The study has been published in the peer-reviewed journal Brain Communications and can be accessed here.

Dr. Fred Grossman, Chief Medical Officer at Coya said, “We believe these biomarker data coupled with the clinical and lab results of the clinical study in FTD provide additional evidence supporting the development of biologic combination therapies that enhance the function of regulatory T cells and target inflammation in FTD, ALS and other neurodegenerative diseases of high unmet need.”

Summary of Study Results

Blood samples were obtained from 27 patients clinically diagnosed with FTD and 25 age-matched healthy individuals as a control group.

Comprehensive analyses revealed significantly lower regulatory T cell (Treg) immunomodulatory suppressive function in FTD patients compared to healthy controls (p<0.05). Transcriptomic profiling of monocytes showed different degrees of dysregulation of immune-related genes in samples from FTD patients. Consistent with the reduced anti-inflammatory function observed in Tregs, proteomic analysis of plasma inflammatory mediators showed a significant increase in the pro-inflammatory cytokine TNFα (tumor necrosis factor-alpha) (p<0.05) and the chemokines CXCL10 (C-X-C motif chemokine ligand 10), CCL3 (C-C motif chemokine ligand 3), CCL19 (C-C motif chemokine ligand 19), CSF1 (macrophage colony-stimulating factor) (p<0.05) and CXCL12 (C-X-C motif chemokine ligand 12) (p<0.01) in FTD patients compared to healthy controls.

The Company believes the results of this study demonstrate that there is a dysregulation of inflammation-related gene expression in peripheral monocytes and an increase of plasma inflammatory chemokines and cytokines in FTD. In addition, the data provide evidence of compromised immunomodulatory function of Tregs.

The Company believes that biomarker data from this research study further support the previously reported findings of an academic clinical study of low-dose interleukin 2 (LD IL-2) and CTLA-4 Ig in patients with FTD. The subcutaneous administration of LD IL-2 and CTLA-4 Ig significantly increased the number and function of Tregs as early as 2 weeks after initiation of treatment and remained elevated throughout the study. Consistent with the improvement of Treg immunomodulatory function, study patients did not show clinical cognitive decline as measured by the validated tools MoCA (Montreal Cognitive Assessment) and CDR-FTLD (Clinical Dementia Rating-Frontotemporal Lobar Degeneration module) over the 22-week treatment period. Overall, treatment with LD IL-2 and CTLA-4 Ig was well tolerated. The most frequent adverse events were mild injection-site erythema.

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

About Frontotemporal Dementia

Frontotemporal dementia (FTD) also referred as frontotemporal lobar degeneration (FTLD), is a progressive neurodegenerative orphan disease affecting the frontal and temporal lobes, causing changes in behavior, language, and personality rather than initial memory loss. It is the most common dementia for people under 60, typically surfacing between ages 45-65, with symptoms worsening over time. There is no currently approved treatment to modify the progression of FTD.¹

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 comprises 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 and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects.

Coya is currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (ClinicalTrials.gov Identifier: NCT 07161999).

COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.

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