What is the story about?
What's Happening?
Coya Therapeutics 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. COYA 302 is a biologic combination therapy designed to enhance regulatory T cell function and suppress inflammation. The trial aims to assess the long-term safety and efficacy of COYA 302, offering a potential new treatment for ALS, a disease with high unmet medical need.
Why It's Important?
ALS, also known as Lou Gehrig's Disease, is a progressive neurological disorder with limited treatment options. The ALSTARS Trial represents a significant step towards developing a novel therapy that targets the underlying mechanisms of ALS. By enhancing regulatory T cell function, COYA 302 could offer a new approach to managing the disease, potentially improving patient outcomes and quality of life. The trial's success could pave the way for further research and development in neurodegenerative disorders, highlighting the importance of innovative therapies in addressing unmet medical needs.
What's Next?
Following the initial 24-week treatment phase, participants will be invited to join a 24-week extension period to further evaluate COYA 302's long-term effects. Coya Therapeutics will present the study details during the NEALS Educational Webinar on September 29, 2025. The company will continue to monitor trial progress and gather data to support potential regulatory submissions. If successful, COYA 302 could become a key player in the ALS treatment landscape, prompting further investment in Treg-enhancing therapies.
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