Coya Therapeutics, Inc. announces that it is expanding its pipeline in neurodegenerative conditions for COYA 302 beyond ALS to include frontotemporal dementia (FTD) and Parkinson?s disease (PD). FTD and PD share a similar disease pathogenesis to ALS that is associated with a heightened proinflammatory cascade involving dysfunctional Tregs and proinflammatory microglia and macrophages. The biological redundancies in molecular immune pathways in these complex diseases limit the efficacy of many single drug therapies, requiring the development of novel therapeutics that can address this pathophysiologic complexity.

COYA 302 is a dual-mechanism investigational biologic combination immunotherapy comprised of proprietary low dose IL-2 and fusion protein CTLA-4 Ig. Low dose IL-2 enhances anti-inflammatory Treg function and numbers while the fusion protein CTLA-4 Ig suppress proinflammatory cell function, enabling potentially synergistic mechanisms in modulating inflammatory pathways and restoring immune balance. COYA 302 has the potential to be disease modifying by targeting multiple dysregulated immune pathways while restoring function in anti-inflammatory Treg function.

Coya intends to file an IND for COYA 302 for the treatment of ALS in the first half of 2024 and an IND for COYA 302 for the treatment of FTD before the end of 2024. In addition, studies in animal models of PD are planned in 2024, and based on those studies, a subsequent IND filing is anticipated for the treatment of PD.