What is the story about?
What's Happening?
Coya Therapeutics, Inc., a biotechnology company based in Houston, has launched the ALSTARS Trial, a Phase 2 clinical study to evaluate the efficacy and safety of COYA 302 in treating Amyotrophic Lateral Sclerosis (ALS). The trial is a randomized, multi-center, double-blind, placebo-controlled study involving 120 participants across 25 centers in the U.S. and Canada. Participants will receive either COYA 302 or a placebo over a 24-week period, with an option to continue in a 24-week extension phase where all will receive COYA 302. COYA 302 is a biologic combination therapy designed to enhance regulatory T cell function and suppress inflammation. The trial aims to address the high unmet medical need in ALS treatment.
Why It's Important?
ALS, a progressive neurological disease affecting motor neurons, has limited treatment options and no cure. The launch of the ALSTARS Trial represents a significant step in developing new therapies for ALS, potentially offering improved outcomes for patients. COYA 302's mechanism of enhancing regulatory T cell function could provide a novel approach to managing systemic inflammation associated with ALS. Success in this trial could lead to advancements in ALS treatment, impacting the lives of approximately 20,000 individuals living with the disease in the U.S.
What's Next?
The trial will be presented during the NEALS Educational Webinar on September 29, 2025, by Dr. James Berry. As the trial progresses, Coya Therapeutics will continue to monitor patient enrollment and dosing, with the potential for COYA 302 to achieve applicable endpoints in clinical trials. The company aims to obtain regulatory approval based on trial results, which could pave the way for commercialization and broader access to this investigational therapy.
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