Coya Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative therapeutic agents that fine-tune the function of regulatory T cells (Tregs). Its therapeutic pipeline leverages diverse approaches, including biologics designed to enhance Treg activity, Treg-derived exosomes, and personalized autologous Treg cell therapies. Among its lead candidates is COYA 101, an autologous regulatory T-cell product that has successfully completed Phase 2a clinical trials for treating Amyotrophic Lateral Sclerosis (ALS). Moving towards Investigational New Drug (IND) applications are two key candidates: COYA 301 and COYA 302. COYA 301 is a Treg-enhancing biologic aimed at treating Frontotemporal Dementia. Meanwhile, COYA 302 is a dual-action biologic combination, suitable for subcutaneous or intravenous delivery, engineered to not only boost Treg function but also to diminish harmful T effector cell activity and activated macrophages in neurodegenerative and autoimmune disorders. Additionally, Coya has earlier-stage programs, including COYA 201, an allogeneic (off-the-shelf) Treg exosome candidate in preclinical development for a range of neurodegenerative, autoimmune, and metabolic conditions. Its pipeline also features COYA 206, an antigen-directed Treg-derived exosome product, currently in the discovery phase. Established in 2020, Coya Therapeutics maintains its headquarters in Houston, Texas.
Coya Therapeutics Announces Completion of Full Enrollment in Phase 2/3 ALSTARS Trial of COYA 302 for the Treatment of ALS
Coya Therapeutics completed full enrollment of 120 participants in its Phase 2/3 ALSTARS trial of COYA 302 in ALS, with additional screened patients still eligible to enroll.
Topline data from the 24-week double-blind, placebo-controlled phase remain on track for early Q2 2027 — the first randomized efficacy readout for the program.
COYA 302 holds FDA Fast Track designation, and partner Dr. Reddy's holds ex-Japan/South America/Mexico commercialization rights under a December 2023 collaboration.