Coya Therapeutics Announces Positive Interim Results of an Investigator-Initiated Open Label Study with Low-Dose IL-2 and CTLA4-Ig Combination Treatment in Five Patients with Mild to Moderate Frontotemporal Dementia

• Results from the first patient cohort (N=5) of an open-label proof of concept academic study with low-dose IL-2 and CTLA4-Ig demonstrated a rapid and durable statistically significant increase in the number and suppressive function of Tregs compared to baseline values.

• Clinically, patients with Frontotemporal Dementia (FTD) demonstrated minimal to no cognitive decline throughout the study period. Treatment was well tolerated, no serious adverse events were reported, and all 5 patients completed the study.

HOUSTON, TX / ACCESS Newswire / April 24, 2025 / Coya Therapeutics, Inc. (NASDAQ:COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function announced positive interim results of an investigator-initiated proof of concept open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD). The study is led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, followed by a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up. The study aims to enroll up to 10 patients, and these interim results include data from the first 5 patients with mild to moderate FTD who have completed the full course of treatment.

Dr. Arun Swaminathan, Coya's Chief Executive Officer followed: "The results thus far are consistent with previously published encouraging data from an open-label investigator-initiated study of patients with ALS treated with low-dose IL-2/CTLA4-Ig. This interim data in FTD provides us further confidence of our approach to target and enhance Treg biology to address devastating neurodegenerative diseases including ALS and FTD".

Previous biomarker data presented by the Company demonstrated that FTD patients exhibit a compromised immunosuppressive function of regulatory T cells (Tregs), along with increased peripheral levels of inflammatory cytokines and chemokines, dysregulation of monocytes, and systemic activation of the inflammatory cascade, supporting the critical role of the immune system in the pathophysiology of FTD.