Coya Therapeutics Reports Additional Proof-of-Concept Clinical Biomarker Data in Patients with Alzheimer’s Disease

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, today reported results from an open-label proof-of-concept clinical study for ld IL-2 in patients with AD. Results of the study were presented July 16, 2023, at the Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands. The poster can be accessed here.

The study enrolled 8 patients with confirmed presence of brain amyloid pathology and baseline MMSE scores 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. Treg function and numbers, serum biomarkers of inflammation, safety and tolerability, and cognitive functioning as measured by the ADAS-Cog, CDR-SB and MMSE assessment tools were evaluated.

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.

Coya previously reported that the treatment with ld IL-2 significantly expanded Treg population and function. At baseline, the mean (SD) percentage of Tregs was 4.55 (1.97) and was almost double at the end of the treatment [8.68 (2.99), p=0.0004]. Mean (SD) Treg suppressive function was 46.61% (7.74) at baseline, and significantly increased to 79.5 % (20.55) at the end of treatment (p=0.003).

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 appeared to be 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.

Following the encouraging results of this open-label proof-of-concept study, a Phase 2 double-blind, placebo-controlled study in approximately 46 patients with mild-to-moderate AD is being conducted at the Houston Methodist Hospital and as of today, is almost fully enrolled with 38 patients in the study. The well-controlled clinical study will evaluate the safety and tolerability, Teg function, blood biomarkers of neuroinflammation, and efficacy of two dose regimens of ld IL-2 compared to placebo, over a 30-week period. Top-line results are anticipated in July 2024. The study is funded by the Gates Foundation and the Alzheimer’s Association.