Coya Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

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Coya Therapeutics (NASDAQ:COYA) has received FDA acceptance of its Investigational New Drug (IND) application for COYA 302, a proprietary immunomodulatory biologic combination therapy for treating Amyotrophic Lateral Sclerosis (ALS). The acceptance enables the company to proceed with a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the treatment's efficacy and safety.

The milestone triggers a $4.2 million payment to Coya from its partner Dr. Reddy's Laboratories (DRL). The development represents a significant step in Coya's partnership with DRL to advance potential treatments for ALS patients.

FDA acceptance enables initiation of a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS

HOUSTON, Aug. 25, 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, announces that the U.S. Food and Drug Administration ("FDA" or the "Agency") has accepted its Investigational New Drug (IND) application for COYA 302. This proprietary immunomodulatory biologic combination therapy is being developed for the treatment of patients with amyotrophic lateral sclerosis (ALS). 

Arun Swaminathan, Chief Executive Officer, added: "The FDA's acceptance of this IND marks a pivotal moment in Coya's journey. We are now preparing to initiate a well-powered, well-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of COYA 302 in patients with ALS. We are grateful to the ALS community for their continued support of this important program."

Milan Kalawadia, Chief Executive Officer, North America, at Dr. Reddy's Laboratories Ltd. ("DRL") stated, "We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study. This milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya. We are energized by the potential of moving a step closer to offering a treatment for patients living with ALS, also known as Lou Gehrig's disease."

The approval of the IND by the FDA triggers a $4.2 million milestone payment to Coya from DRL.

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 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, and 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 Dr. Reddy's Laboratories Limited

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.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 press release, 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 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 will 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

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SOURCE Coya Therapeutics

FAQ

What is the significance of FDA's IND acceptance for Coya Therapeutics (NASDAQ:COYA)?

The FDA's IND acceptance allows Coya to initiate a Phase 2 multicenter clinical trial for COYA 302 in ALS patients, marking a crucial advancement in the drug's development process.

What type of clinical trial will Coya Therapeutics conduct for COYA 302?

Coya will conduct a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in ALS patients.

How much milestone payment will Coya receive for the FDA IND acceptance?

The FDA IND approval triggers a $4.2 million milestone payment to Coya from Dr. Reddy's Laboratories.

What is COYA 302 being developed to treat?

COYA 302 is being developed as a proprietary immunomodulatory biologic combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease.

Who is Coya Therapeutics partnering with for COYA 302 development?

Coya Therapeutics is partnering with Dr. Reddy's Laboratories (DRL) for the development of COYA 302.