HOUSTON, Texas — Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, today announced that the 100th patient has been enrolled in the Company’s ongoing Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302, Coya’s combination of proprietary low-dose IL-2 and CTLA-4 Ig, for the treatment of amyotrophic lateral sclerosis (ALS). Based on current enrollment trends, Coya anticipates completing full enrollment of 120 participants in sufficient time to permit reporting topline data in early Q2 of 2027.
“Enrollment of the 100th participant in the ALSTARS trial represents a critical milestone for Coya and brings us closer to completing this important Phase 2/3 study,” said Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya. “Our current screening and enrollment rates have been consistent, and we project that all 120 participants will be enrolled in the upcoming weeks and on target for a topline readout in early Q2 2027.”
“We are deeply grateful to the patients, caregivers, investigators, and clinical site teams whose participation and commitment continue to make the ALSTARS trial possible. We look forward to topline data and believe that, if positive, COYA 302 has the potential to significantly alter the course of this devastating disease and offer new hope to people living with ALS and their families,” Dr. Grossman concluded.
About Amyotrophic Lateral Sclerosis (ALS)
ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord that control voluntary muscles, including those needed to speak, swallow, and breathe. The disease progresses rapidly, with patients experiencing an average decline of approximately one point per month on the ALS Functional Rating Scale-Revised (ALSFRS-R), and 20% to 30% of patients dying within two years of diagnosis despite available therapies. Approximately 90% of ALS cases are sporadic, occurring in people with no family history of the disease. Current approved therapies provide only a modest treatment effect and slow, but do not stop, disease progression and functional decline, underscoring the significant unmet need for new treatment options that can meaningfully alter the course of the disease.
About the ALSTARS Trial
The ALSTARS Trial is a Phase 2/3, randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of COYA 302 in patients with ALS. Approximately 120 subjects will be randomized 1:1:1 to receive one of two pre-specified dosing regimens of COYA 302 or placebo during a 24-week double-blind treatment phase. Patients who complete the 24-week placebo-controlled phase enter a 24-week blinded active-treatment extension phase; patients receiving COYA 302 continue their assigned regimen, while placebo patients are re-randomized to one of the two COYA 302 dosing regimens, providing up to 48 weeks of data on COYA 302.
The primary endpoint is change in disease severity over time, measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score from baseline to Week 24 compared with placebo. Study objectives include evaluation of efficacy, safety and tolerability, biological activity, and biomarker levels.
To learn more about the study, please visit ALSTARS Trial.
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 and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects.
Coya is currently conducting the ALSTARS Trial, a Phase 2/3, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (Identifier: NCT07161999).
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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