Coya Therapeutics Announces Results of Investigator-Initiated Study of LD IL-2 and CTLA4-Ig Demonstrating Treg Enhancement and Cognitive Stability in Frontotemporal Dementia Patients

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Key Terms

regulatory T-cell (Treg) medical

Regulatory T cells (Tregs) are a specialized type of immune cell that act like peacekeepers, calming or restraining other immune cells to prevent excessive inflammation or attacks on the body’s own tissues. For investors, Tregs matter because they are key targets or safety considerations in drug development: boosting them can treat autoimmune disease while blocking them can help cancer therapies, so therapies that affect Tregs can drive both efficacy and risk.

CTLA4-Ig medical

CTLA4‑Ig is a lab-made protein that combines the immune‑system’s natural “off” switch for T cells (CTLA‑4) with part of an antibody to make it stable and long‑lasting in the body. It acts like a molecular brake to dampen overactive immune responses, so it’s used as a therapeutic approach for autoimmune diseases and immune-related conditions. Investors care because clinical trial results, safety, and regulatory decisions for drugs using this mechanism can strongly affect commercial potential and company value.

IL-2 medical

Interleukin-2 (IL-2) is a small protein the body uses as a messenger to tell immune cells when to grow and act, like a coach sending signals to players on a team. For investors, IL-2 matters because drugs that boost, mimic, or block its activity can change how well immune therapies work and what side effects they cause, affecting clinical trial success, regulatory approval prospects, and commercial value.

Montreal Cognitive Assessment (MoCA) medical

A brief, standardized clinical test that checks a person’s thinking skills—such as memory, attention, language and problem-solving—using simple tasks like drawing, word recall and clock-reading. Investors care because MoCA scores are commonly used as an outcome or screening measure in drug and device studies for cognitive disorders; changes in those scores can influence trial success, regulatory decisions and the commercial prospects of treatments. Think of it as a quick check-up for brain function that helps judge whether a therapy is working.

CDR-FTLD medical

A clinician-rated scale adapted from the Clinical Dementia Rating to assess symptoms and daily functioning in people with frontotemporal lobar degeneration (a form of early-onset dementia). Think of it like a detailed report card doctors use to score cognition, behavior and ability to manage everyday tasks. Investors watch this measure because it is often used as a trial endpoint and can strongly influence a drug’s perceived effectiveness, regulatory approval prospects and market value.

mean fluorescence intensity (MFI) medical

Mean fluorescence intensity (MFI) is the average brightness measured from fluorescently labeled cells or particles in a lab test, reflecting how much of a specific molecule (like a protein or drug) is present or bound. For investors, MFI is a quantitative readout of biological activity or assay performance—higher or lower values can signal whether a therapy, diagnostic or biomarker is working as intended, similar to judging how brightly bulbs glow to assess if a light system is functioning properly.

FOXP3 medical

FOXP3 is a gene that produces a protein serving as a master switch for regulatory T cells, the immune system’s brakes that prevent excessive inflammation and autoimmune reactions. Investors care because therapies or diagnostics that target FOXP3 can alter immune behavior and become treatments or biomarkers for autoimmune disease, cancer immunotherapy, or transplant rejection, influencing clinical trial success, regulatory decisions, and commercial value much like a control knob that shifts therapeutic effects.

erythema medical

Erythema is redness of the skin caused by increased blood flow to an area, often appearing like a sunburn or flushed patch and resulting from irritation, inflammation, allergic reaction, infection, or a treatment’s side effect. For investors, erythema matters because it is a visible safety or tolerability signal in clinical trials and product use that can affect regulatory decisions, prescribing, consumer acceptance, and ultimately a company’s revenue and stock value.

01/08/2026 - 08:00 AM

Robust target engagement was observed, with statistically significant increases in regulatory T-cell (Treg) suppressive function and Treg numbers beginning as early as two weeks post-dosing and sustained through the 22-week treatment period.

Cognitive measures remained stable, with no evidence of cognitive decline or meaningful change from baseline in either the Montreal Cognitive Assessment (MoCA) or the CDR-FTLD scores over 22 weeks.

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, today announced positive results of an investigator-initiated proof of concept open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in 9 patients with Frontotemporal Dementia (FTD) over a 6 month period. The study was led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, along with a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up. The study enrolled 9 patients, and data demonstrated enhanced Treg numbers and function and cognitive function stability as measured by CDR-FTLD and Montreal Cognitive Assessment (MOCA).

Dr. Arun Swaminathan, Coya’s Chief Executive Officer followed: “We believe these results suggest the potential for COYA 302 as a therapeutic option for patients with FTD. We look forward to advancing COYA 302 in a well-controlled phase 2 clinical trial in patients with FTD.”

Dr. Fred Grossman, Coya’s Chief Medical Officer said: “We believe this study continues to add evidence that restoring Treg numbers and function has the potential to translate to clinically meaningful effects across multiple neurodegenerative diseases.”

Study Results

The data presentation can be found in this LINK

Safety and feasibility

Nine individuals clinically diagnosed with FTD were enrolled into this study. The primary endpoints were the incidence and severity of adverse events. The most common adverse event was erythema at the injection site (33.3% of individuals), which was mild and recovered spontaneously. No serious adverse events were observed during the study.

Treg Suppression

Treg suppressive function was significantly increased starting as early as 2 weeks after dosing and remained significantly amplified throughout the 22-week treatment period.

Treg Percentage followed a similar pattern as Treg suppressive function, with significant separation from baseline occurring as early as 2 weeks post dosing and remained significantly elevated through week 22.

CD25 mean fluorescence intensity (MFI) was significantly increased as early as 2 weeks after dosing and remained significantly elevated through 22 weeks.

FOXP3 MFI was significantly increased as early as 2 weeks after dosing.

Cognitive Measures

MOCA (Montreal Cognitive Assessment) scores remained unchanged at week 22, compared to baseline (Baseline, 13.5 and week 22, 14) suggesting no decline in cognitive function over the 22-week period.

CDR-FTLD scores did not significantly change at week 22 compared to baseline levels (Baseline, 4.8 and week 22, 5.5), suggesting no decline in cognitive and functional status of the enrolled individuals over the 22-week treatment period.

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.

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 https://coyatherapeutics.com/

Forward-Looking Statements

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