Coya Therapeutics Launches the ALSTARS Trial, a Phase 2 Clinical Study to Assess the Efficacy and Safety of COYA 302 in Amyotrophic Lateral Sclerosis
The ALSTARS Trial is a well powered randomized, multi-center, double-blind, placebo-controlled, 24-week study of COYA 302 in people with Amyotrophic Lateral Sclerosis (ALS)
Patients completing the initial 24-week treatment will be invited to participate in a 24-week blinded extension period, during which all participants will receive COYA 302
The ALSTARS Trial will enroll 120 ALS participants at approximately 25 centers in the United States and Canada
HOUSTON, Sept. 22, 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, announced today the launch of 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).
Eligible study participants will be randomized to receive one of two different doses of COYA 302 or placebo in this 24-week, double-blind study. Participants who complete the initial placebo-controlled phase will be invited to enroll in an additional 24-week blinded extension to assess the long-term safety and efficacy of COYA 302. During this extension, all participants will receive COYA 302 at one of the two prespecified doses.
Study details, including eligibility criteria and current study locations, can be found here. Additional locations will continue to be added. The study will be presented on September 29, 2025, during the NEALS Educational Webinar by Dr. James Berry, MD, MPH and registration can be found here.
Fred Grossman, Chief Medical Officer stated "The launch of the ALSTARS Trial represents a significant milestone in our mission to develop innovative therapies for patients with ALS. We believe COYA 302's unique mechanism of enhancing regulatory T cell number and function offers a promising new approach towards developing a potential therapy for this devastating disease with high unmet medical need. We look forward to evaluating its potential to meaningfully impact the lives of ALS patients and their families."
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 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
- Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725. doi: 10.1212/WNL.0000000000000951.
- 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. 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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