Coya Therapeutics Announces the Completion of a Controlled Phase 2 Study of Low Dose Interleukin-2 (LD IL-2) in Patients with Alzheimer’s Disease

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces the completion of a randomized, double-blind, placebo-controlled Phase 2 study of LD IL-2 in patients with mild-to-moderate AD. The study is being conducted by Drs. Stanley Appel and Alireza Faridar at Houston Methodist Hospital and is funded by the Gates Foundation and the Alzheimer’s Association. Topline results of the study are still anticipated to be reported in summer of 2024.

This controlled Phase 2 study will evaluate the safety, tolerability, and biological activity of LD IL-2 in patients with AD compared to placebo at pre-specified intervals. Additionally, blood and cerebrospinal fluid biomarkers, neuroimaging results, and changes in cognitive function will be evaluated across the different patient populations.

Fred Grossman D.O., President and CMO of Coya Therapeutics, stated, “This is an important study that will help advance our expanding pipeline in dementia. We look forward to unblinding the data from this controlled study in Alzheimer’s Disease and releasing the top-line results this summer.”

In the study, a total of 38 patients were randomly assigned to receive commercial subcutaneous LD IL-2 at two different dosing regimens, or matching placebo, over 21 weeks followed by a 9-week follow-up period after the last dose. The first patient cohort was randomized to receive LD IL-2 for five consecutive days every four weeks and the second cohort was randomized to receive LD IL-2 for five consecutive days every two weeks.

Coya previously reported that treatment with LD IL-2 significantly expanded Treg population and function in an open-label proof-of concept study in eight patients with AD. The mean (SD) percentage of Tregs significantly increased from 4.55 (1.97) at baseline to 8.68 (2.99) [p=0.0004] at the end of treatment. Mean (SD) Treg suppressive function significantly increased from 46.61% (7.74) at baseline to 79.5 % (20.55) at the end of treatment (p=0.003).

In addition, an evaluation of cognitive function showed that administration of LD IL-2 resulted in a statistically significant improvement in mean Mini-Mental State Examination (MMSE) scores during the treatment phase, compared to mean MMSE score at baseline (p=0.015). Consistent with the positive trend in MMSE score, mean scores in ADAS-Cog and CDR-SB scales did not significantly change at the end of treatment with LD IL-2, compared to pre-treatment baseline scores, indicating no cognitive decline as measured by these validated instruments.