Coya Therapeutics Announces Patients Have Been Dosed in the ALSTARS Trial of COYA 302 for the Treatment of ALS

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phase 2 medical

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

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amyotrophic lateral sclerosis medical

A progressive disease in which nerve cells that control voluntary muscles gradually fail, leading to loss of movement, speech and eventually breathing — like an electrical wiring system in the body slowly shorting out. It matters to investors because there are few effective treatments, so clinical trial results, regulatory approvals, new therapies or diagnostics can rapidly change patient care, market opportunity and company valuations.

regulatory T cells medical

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12/09/2025 - 08:00 AM

The ALSTARS Trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of COYA 302 in patients with amyotrophic lateral sclerosis (ALS) being conducted at clinical sites in the United States and Canada

Dosing of ALS patients has commenced in the ALSTARS Trial and signifies a key milestone for the Company.

COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, is designed to enhance the number and function of regulatory T cells while suppressing the pro-inflammatory myeloid activity that drives ALS progression.

COYA will receive a $4.2 million milestone payment from its strategic partner, Dr. Reddy’s Laboratories (DRL), for the achievement of this milestone

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, announced that dosing of ALS patients in the Company’s ALSTARS Trial of COYA 302 has commenced.

Dr. Fred Grossman, the Company’s Chief Medical Officer, said, “We are very pleased that the ALSTARS Trial is underway, and we want to extend our sincere thanks to patients and their families for their participation in this important study. We believe COYA 302 represents an innovative approach to treating ALS, with a clear and well-characterized mechanism of action focused on both restoring regulatory T-cell (Treg) function and suppressing inflammatory myeloid activity—two key drivers of ALS progression. We believe our strategy of modulating the immune system through combination therapies may offer a novel and potentially transformative therapeutic approach for people living with ALS. This important milestone highlights our commitment to developing COYA 302 for the treatment of this devastating disease.”

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. 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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