Coya Therapeutics announced that the U.S. Food and Drug Administration accepted its Investigational New Drug application for COYA 302, a dual‑biologic therapy that combines low‑dose interleukin‑2 with CTLA‑4 Ig, for the treatment of frontotemporal dementia (FTD). The acceptance clears the company to launch a Phase 2, randomized, double‑blind, placebo‑controlled study in patients with mild‑to‑moderate FTD, extending the reach of its lead asset beyond amyotrophic lateral sclerosis (ALS).
The FDA’s decision removes a critical regulatory hurdle and allows Coya to begin patient enrollment, conduct the trial, and collect data that will inform future regulatory submissions and potential market access for COYA 302 in FTD. The company’s early data in ALS and the planned FTD program underscore a strategy that targets neuroinflammation through regulatory T‑cell (Treg) enhancement, a novel therapeutic approach in neurodegenerative disease.
Coya’s management highlighted the significance of the milestone, noting that the dual mechanism of COYA 302—low‑dose IL‑2 to expand Tregs and CTLA‑4 Ig to dampen inflammation—provides a strong scientific rationale for evaluating the therapy in FTD. The company also emphasized its partnership with Dr. Reddy’s Laboratories, which has provided milestone payments for the ALS program and could offer non‑dilutive funding as the FTD program progresses.
The FDA acceptance positions Coya to pursue a broader neurodegenerative indication portfolio, including Parkinson’s disease and Alzheimer’s disease, and supports an estimated market opportunity of over $10 billion across these indications. The company’s strong cash position and absence of debt give it the financial flexibility to advance the FTD trial while continuing to invest in its ALS program.
Coya’s leadership expressed confidence that the Phase 2 study will generate robust clinical evidence, potentially opening a multi‑billion‑dollar market if the results are positive. The company’s focus on Treg dysfunction as a common driver of neuroinflammation aligns with emerging evidence that immune modulation can alter disease trajectories in FTD and other neurodegenerative disorders.
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