HOUSTON, Texas, June 8, 2026
Coya Therapeutics, Inc. announced a significant milestone in the ongoing ALSTARS clinical trial, with the first cohort of patients entering the blinded active-treatment extension phase of the study evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS). The advancement follows completion of the initial 24-week double-blind, placebo-controlled portion of the trial and marks an important step in the continued clinical development of the company’s investigational therapy designed to enhance regulatory T cell (Treg) function and address neuroinflammation associated with ALS.
ALSTARS Trial Moves Into Extension Phase
Patients who successfully complete the first 24 weeks of the ALSTARS Trial are eligible to enter a 24-week blinded extension period. During this phase, participants continue on their assigned treatment regimen while patients previously receiving placebo are re-randomized to one of two predefined dosing regimens of COYA 302. This study design enables researchers to gather up to 48 weeks of clinical data, providing additional insight into the therapy’s long-term safety, tolerability, and potential therapeutic benefits in people living with ALS. The extension phase represents an important component of the trial and may help further characterize the impact of COYA 302 on disease progression.
COYA 302 Targets Neuroinflammation in ALS
COYA 302 is being developed as a novel therapeutic approach aimed at restoring immune balance by enhancing the function of regulatory T cells (Tregs). Growing evidence suggests that impaired Treg activity contributes to chronic inflammation and neurodegeneration in ALS. By improving Treg function, COYA 302 is designed to reduce harmful inflammatory responses that may accelerate neuronal damage and disease progression. The therapy represents part of Coya’s broader strategy to develop treatments targeting the underlying immune dysfunction associated with neurodegenerative diseases rather than focusing solely on symptom management.
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Company Highlights Ongoing Clinical Progress
Coya Therapeutics stated that the initiation of the extension phase reflects steady progress in the ALSTARS program and continued participation from patients, caregivers, and clinical investigators. The company noted that ongoing enrollment and patient retention remain critical to generating meaningful clinical data that could support future development decisions. As the study advances, researchers will continue evaluating outcomes related to disease progression, functional measures, and safety parameters to determine the therapeutic potential of COYA 302 in ALS.
Expanding a Treg-Based Therapeutic Pipeline
Beyond COYA 302, Coya Therapeutics is building a broader portfolio of therapies focused on enhancing or restoring the function of regulatory T cells. The company’s pipeline includes Treg-enhancing biologics, Treg-derived exosome therapies, and autologous Treg cell therapies aimed at addressing diseases characterized by chronic inflammation and immune dysregulation. These programs target a range of conditions including neurodegenerative disorders, autoimmune diseases, and metabolic diseases. The continued advancement of the ALSTARS Trial strengthens Coya’s position in the growing field of immune-modulating therapies and highlights its commitment to developing innovative treatment options for patients with serious neurological disorders.
Source: Coya Therapeutics press release
