Coya Therapeutics' Alzheimer's Candidate Shows Lower Biomarker Levels Associated With Neuroinflammation

Coya Therapeutics Inc COYA reported results from an open-label proof-of-concept clinical study for low-dose interleukin 2 (ld IL-2) in patients with Alzheimer's disease (AD). 

The study enrolled eight patients with confirmed brain amyloid pathology and baseline Mini-Mental State Examination test (MMSE) scores, a measure of cognitive function, between 12 and 25. 

The patients were treated with five-day courses of subcutaneous ld IL-2 for four monthly cycles and were followed for two months post-treatment. 

The additional blood biomarker data showing a significant decrease in the blood levels of the proinflammatory cytokines and chemokines CCL4, FLT3LG, and TNFα in AD patients treated with ld IL-2 strengthen the positive results Coya has previously announced in May 2023.

In addition, evaluation of cognitive function showed that administration of ld IL-2 resulted in a statistically significant improvement in mean 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 COYA 301, compared to pre-treatment baseline scores, indicating no cognitive decline as measured by these validated instruments.

Overall, administration of ld-IL-2 was safe and well tolerated. The most common adverse events were mild injection-site reactions and mild leukopenia. No serious adverse events were reported, and no patient discontinued the study.

A Phase 2 study is being conducted in approximately 46 patients with mild-to-moderate AD at the Houston Methodist Hospital. Top-line results are anticipated in July 2024. 

Price Action: COYA shares are up 2.99% at $4.13 on the last check Monday.