Biotechnology company Coya Therapeutics announced that the United States Food and Drug Administration had accepted its investigational new drug (IND) application for its COYA 302 experimental therapy for FTD. The acceptance of the application will enable Coya Therapeutics to initiate clinical trials for the therapy in the U.S.

COYA 302 Combination Therapy is Designed to Target Neuroinflammation

In FTD and other neurodegenerative disorders, neuroinflammation is thought to contribute to the progression of the disorder. Researchers at Coya Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases. This cellular dysfunction may lead to sustained inflammation and stress, resulting in a lack of balance in the immune system. COYA 302 combines two compounds, IL-2 and CTLA4-lg, to address T cell dysfunction in what is known as a “combination therapy.”

• IL-2: Assists T cells in various ways to support their development and survival.
• CTLA4-lg: Helps regulate the immune system through selective depletion of activated immune cells.

In May 2025, a small number of participants showed an increase in regulatory T cell numbers and a partial restoration of immune system moderation. The company plans to release the final results from this study in the coming weeks.

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