COYA 302's ALSTARS Phase 2 readout will determine whether Treg-based immunomodulation can alter ALS disease course in a randomized controlled trial

Coya Therapeutics is a clinical-stage biopharmaceutical company developing a cell-based immunotherapy for amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease, and the treatment is not yet approved.

COYA 302, a combination of low-dose IL-2 and CTLA4-Ig designed to expand regulatory T cells, is in an active Phase 2 randomized controlled trial in ALS patients. The thesis resolves on the ALSTARS topline readout: whether COYA 302 achieves a statistically significant functional or survival benefit versus placebo. Riluzole, edaravone, and Biogen's tofersen set a high efficacy bar, and Keros Therapeutics' rinvatercept and Clene's CNM-Au8 represent active competing mechanisms in the same patient pool.