Coya Therapeutics (COYA) Study Update summary

Study background and rationale

• Focus on addressing neuroinflammation in neurodegenerative diseases by modulating regulatory T cells (Tregs).

• Coya 301 is a proprietary low-dose recombinant human IL-2 designed to expand and restore Treg function.

• Combination approaches, such as Coya 302 (IL-2 plus CTLA-4 Ig), are being developed for broader efficacy.

• Dysfunctional Tregs are linked to disease progression; restoring Treg function is hypothesized to slow or halt decline.

Study design and objectives

• Phase 2, randomized, double-blind, placebo-controlled trial evaluated subcutaneous low-dose IL-2 in 38 Alzheimer's patients aged 50–86 with MMSE scores 12–26.

• Patients received IL-2 every four weeks (n=9), every two weeks (n=10), or placebo (n=19) over 21 weeks, with 9-week post-treatment follow-up.

• Primary endpoint was safety and tolerability; secondary endpoint was Treg expansion; exploratory endpoints included cognitive scales and CSF biomarkers.

• Study funded by Alzheimer's Association, Gates Foundation, and NIA, with Coya support.

Safety and tolerability outcomes

• Low-dose IL-2 was safe and well tolerated, with no serious adverse events or deaths; most common adverse events were mild injection site erythema and transient eosinophilia.

• All subjects completed the treatment phase.