Coya Therapeutics' COYA 302 ALS Trial Accepted by NEALS as a NEALS-Affiliated Trial

NEALS, the world's largest ALS research consortium, has selected the COYA 302 trial and it is now affiliated with NEALS as part of its mission to accelerate the development of new treatments for people living with ALS;

Following FDA's recent acceptance of the COYA 302 IND, Coya plans to initiate its Phase 2 study in people with ALS in Q4 2025;

The COYA 302 study will be presented during the NEALS Educational Webinar on September 29, 2025.

HOUSTON, Sept. 4, 2025 /PRNewswire/ -- 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 that its upcoming Phase 2 clinical trial to evaluate the efficacy and safety of COYA 302 in patients with ALS has been accepted as a NEALS-Affiliated Trial by the NEALS Consortium.

The NEALS Consortium is the world's largest ALS research network, comprising a highly active group of trial-ready sites with deep expertise in designing and managing FDA-regulated clinical studies. For more than 30 years, NEALS has partnered successfully with both industry and academic investigators to conduct high-quality ALS trials, guided by a seasoned leadership team committed to accelerating treatment development for people living with ALS.

As a NEALS-affiliated study, the COYA 302 Phase 2 clinical trial will benefit from broad support across NEALS' institutional and community networks, enhancing operational execution and maximizing clinical impact. The study will be presented on September 29, 2025, during the NEALS Educational Webinar by James Berry, MD, MPH — Winthrop Family Scholar in ALS Sciences, Averill Healey Endowed Chair in ALS, and Chief of the Division of ALS and Motor Neuron Diseases at Mass General Hospital.

"We are honored that our COYA 302 trial has been recognized by NEALS and look forward to working closely with their network of leading ALS investigators, clinical centers, and patient outreach groups," said Dr. Fred Grossman, President and Chief Medical Officer. "This important affiliation further advances our commitment to advancing new treatments for people living with ALS."

Dr. Berry stated, "The COYA 302 trial represents an innovative approach to ALS treatment through its focus on enhancing regulatory T cell function. The affiliation of this Phase 2 trial with NEALS underscores the potential significance of Coya's therapeutic approach for the ALS community. We are pleased to present this study during our NEALS Educational Webinar."

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 is comprised of 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. These mechanisms may have additive or synergistic effects.

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

About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, is a rare neurological disease that affects motor neurons, the nerve cells in the brain and spinal cord that control voluntary muscle movement.  About 20,000 people live with ALS in the United States and approximately 5,000 new cases are diagnosed every year.  The disease is progressive, meaning the symptoms get worse over time. The functional status of ALS patents declines about 1 point per month on average, as measured by the Revised ALS Function Rating Scale¹, or ALSFRS-R, a validated tool to monitor the progression of the disease.  ALS has no cure, and the currently approved drug treatments provide limited benefit to patients.  ALS is a type of motor neuron disease. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch (fasciculations), and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear.²

1. Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725. doi: 10.1212/WNL.0000000000000951.
2. National Institutes of Health (NIH) Website (https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als), accessed on January 4, 2023.

About the NEALS Consortium
Founded in 1995, NEALS (neals.org) is a global network of over 150 research centers, including over 100 clinical trial sites in the US and Canada, dedicated to developing and conducting clinical trials for amyotrophic lateral sclerosis (ALS) and related motor neuron diseases. NEALS has been recognized for its contributions to ALS research, notably in trials that have slowed ALS progression and improved patient survival. It offers an online database of ALS clinical trials, provides support to individuals with ALS and their families, and offers educational programs, such as the ALS Clinical Research Learning Institute. 

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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SOURCE Coya Therapeutics, Inc.