Coya Therapeutics Announces Pipeline Expansion of COYA 302 to Include Frontotemporal Dementia and Parkinson’s Disease in Addition to Amyotrophic Lateral Sclerosis

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, 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). The Company’s updated pipeline can be viewed here.

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.

Dr. Fred Grossman, Coya’s President and Chief Medical Officer stated, “ALS, FTD, and PD are driven by a similar, yet complex, proinflammatory environment that requires targeting more than a single pathway. COYA 302 has been designed to target multiple pathways, such as restoring dysfunctional Tregs and inhibiting proinflammatory microglia and macrophages, and may have disease modifying potential in these severe diseases with high unmet need.”

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.

Howard H. Berman, Ph.D., Coya’s CEO stated: “Our vision has always been to leverage the potential of Tregs in neurodegenerative diseases. With COYA 302, we have taken a page from the playbook of oncology and viral disease where combination therapies have been transformational. We believe that the complementary and possibly synergistic multi-mechanism mode of action of COYA 302 in targeting the complex immune environment will lead to promising clinical outcomes in patients with neurodegenerative diseases.”