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

Rhea-AI Summary

Coya Therapeutics (NASDAQ: COYA) announced that its Phase 2 clinical trial for COYA 302 in ALS patients has been accepted as a NEALS-Affiliated Trial by the NEALS Consortium, the world's largest ALS research network. The trial, following FDA's recent IND acceptance, is scheduled to begin in Q4 2025.

The study will be presented during the NEALS Educational Webinar on September 29, 2025, by Dr. James Berry from Mass General Hospital. As a NEALS-affiliated study, COYA 302's trial will receive broad support across NEALS' institutional and community networks, enhancing operational execution and clinical impact.

Positive

• NEALS affiliation provides access to world's largest ALS research network and trial-ready sites
• FDA recently accepted COYA 302's IND application
• Trial benefits from NEALS' expertise in FDA-regulated clinical studies

Negative

• Phase 2 trial yet to begin, with results still pending
• No efficacy or safety data available yet for COYA 302 in ALS patients

Insights

Biotechnology Clinical Trials Expert

COYA's NEALS affiliation bolsters credibility for upcoming ALS trial, providing operational support and increasing visibility for their innovative Treg therapy approach.

This NEALS affiliation represents a significant operational milestone for Coya Therapeutics' COYA 302 ALS program. NEALS isn't just any organization - it's the world's largest ALS research network with over three decades of experience conducting FDA-regulated clinical studies. This partnership provides Coya access to NEALS' extensive network of trial-ready sites with specialized expertise in ALS trials.

The timing is particularly strategic, following the recent FDA acceptance of their IND, with the Phase 2 trial set to begin in Q4 2025. NEALS affiliation delivers three critical benefits: cost-efficient trial execution through established infrastructure, accelerated patient recruitment through NEALS' patient outreach networks, and enhanced protocol quality from input by leading ALS experts.

COYA 302's mechanism targets regulatory T cell (Treg) enhancement, addressing the neuroinflammatory component of ALS pathology. This approach differentiates it from many existing ALS therapies that primarily target neuronal survival directly. The presentation at the upcoming NEALS Educational Webinar by Dr. James Berry, a prominent ALS expert from Mass General Hospital, further validates scientific interest in this approach.

While not guaranteeing clinical success, this affiliation significantly strengthens Coya's operational foundation for executing their upcoming Phase 2 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 

Forward-Looking Statements
This press release contains "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact 
David Snyder, CFO
david@coyatherapeutics.com

astr partners
Matthew Beck
matthew.beck@astrpartners.com 
917-415-1750

Media Contacts
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646-942-5595

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SOURCE Coya Therapeutics, Inc.

FAQ

When will Coya Therapeutics (NASDAQ: COYA) begin its Phase 2 trial for COYA 302 in ALS patients?

Coya Therapeutics plans to initiate its Phase 2 study for COYA 302 in Q4 2025, following FDA's recent IND acceptance.

What is the significance of NEALS affiliation for Coya's COYA 302 ALS trial?

NEALS affiliation provides access to the world's largest ALS research network, offering broad institutional support, expertise in FDA-regulated studies, and enhanced operational execution.

When and where will Coya Therapeutics present the COYA 302 study details?

The study will be presented during the NEALS Educational Webinar on September 29, 2025, by Dr. James Berry from Mass General Hospital.

What is COYA 302's therapeutic approach for treating ALS?

COYA 302 focuses on enhancing regulatory T cell (Treg) function in patients with ALS, representing an innovative approach to treatment.

Who will be leading the presentation of Coya's ALS trial at the NEALS webinar?

Dr. James Berry, Chief of the Division of ALS and Motor Neuron Diseases at Mass General Hospital, will present the study.