Coya completes enrollment in phase 2 well-controlled study of mild-moderate AD

Coya Therapeutics announced completion of enrollment in a randomized, double-blind, placebo-controlled phase 2 study of LD IL-2 in patients with mild-to-moderate AD….This phase 2 well-controlled study will evaluate the safety and tolerability, biological activity, blood and cerebrospinal fluid biomarkers, neuroimaging, and changes in cognitive function of LD IL-2 compared to placebo at pre-specified timepoints over the course of the 21-week treatment period and at 9 weeks after the last dose of study treatment. Topline results of the study are anticipated to be reported in Summer 2024. The study is funded by the Gates Foundation and the Alzheimer’s Association…Coya previously reported that the treatment with LD IL-2 significantly expanded Treg population and function in an open-label proof-of concept study in 8 patients with AD. At baseline, the mean percentage of Tregs was 4.55 and Overall, administration of LD IL-2 appeared to be well tolerated in the 8 patients in the open-label, proof-of concept study. 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.