Coya Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Frontotemporal Dementia (FTD)

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Key Terms

investigational new drug (ind) regulatory

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

frontotemporal dementia (ftd) medical

A progressive brain condition that damages the parts of the brain controlling behavior, language and movement, causing personality changes, trouble speaking or problems with coordinating actions. For investors, it matters because the limited treatment options and predictable course create clear commercial and regulatory opportunities and risks for drug makers, diagnostics and care providers—think of it as aging wiring in a house that requires expensive repairs and creates clear demand for solutions.

regulatory t cell (treg) medical

Regulatory T cells (Tregs) are a specialized type of white blood cell that act like the immune system’s brake, helping prevent excessive or misdirected attacks on the body by calming other immune cells. For investors, Tregs matter because therapies that boost, block, or measure them can change how well treatments for autoimmune disease, cancer, and transplant rejection work and how safe they are, making Tregs a common drug target and biomarker in biotech.

neuroinflammation medical

Neuroinflammation is the brain or spinal cord’s immune reaction to injury, infection, or abnormalities, where cells and molecules become active to protect or repair nervous tissue. It matters to investors because it underlies many neurological diseases and is a common target for drugs and diagnostic tools; positive or negative trial results, safety signals, or new therapies can change a company’s value much like a major repair plan or recall would affect a carmaker’s prospects.

open-label study medical

An open-label study is a type of research where both the participants and the researchers know which treatment or intervention is being administered. This transparency can influence the results, making it important for investors to consider potential biases or limitations when evaluating the study’s findings. Understanding this helps assess the reliability of evidence supporting new products or therapies.

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.

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.

01/05/2026 - 08:00 AM

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, announces that the U.S. Food and Drug Administration (FDA) has accepted the Company’s IND for COYA 302 for the treatment of frontotemporal dementia (FTD).

FTD is the most common form of dementia in people under the age of 65, affecting about 60,000 Americans. The average age of onset is 58, with an average survival time of 7.5 years.FTD is characterized by loss of intellectual functions, such as memory problems, impaired abstract thinking, reasoning, and executive function, that are severe enough to hamper activities of daily living. The clinical manifestations include behavior changes, dietary changes, loss of empathy, apathy, and executive function. FTD constitutes a high unmet medical need, as there is no treatment to stop or ameliorate the progression of the disease.

Dr. Adam Boxer, Professor of Neurology at UCSF and a noted FTD clinical trials expert, said, “There is a great need to develop disease modifying treatments for patients with FTD since none exist today. I am pleased to see this new treatment approach with a strong scientific rationale being moved forward toward a clinical trial for sporadic FTD. I commend Coya for advancing COYA 302 into well-controlled clinical trials for these patients.”

Dr. Fred Grossman, Chief Medical Officer at Coya said, “There is growing evidence for the relationship between neuroinflammation and progression of FTD. We believe the dual mechanism of COYA 302, which is designed to enhance the anti-inflammatory function of Tregs, provides a strong scientific rationale for evaluating this therapy in patients with FTD.”

Coya expects to announce topline results from the previously announced investigator-initiated open-label study evaluating low-dose IL-2 and CTLA4-Ig in patients with mild-to-moderate FTD in the coming weeks.

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 www.coyatherapeutics.com

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