Coya Therapeutics Completes Enrollment in Phase 2 Study of LD IL-2 for Alzheimer’s Disease

Coya Therapeutics, a clinical-stage biotechnology company, has announced the completion of enrollment in a phase 2 study of LD IL-2 for patients with mild-to-moderate Alzheimer’s Disease (AD). The randomized, double-blind, placebo-controlled study is being conducted by Drs. Stanley Appel and Alireza Faridar at the Houston Methodist Hospital.

A total of 38 patients were assigned to receive subcutaneous LD IL-2 at two different dosing regimens or a placebo over a 21-week period. The study aims to evaluate the safety and tolerability of LD IL-2 compared to placebo, as well as its biological activity, biomarkers, neuroimaging, and changes in cognitive function. Topline results are expected to be reported in Summer 2024. The study is funded by the Gates Foundation and the Alzheimer’s Association.

Coya Therapeutics previously conducted an open-label proof-of-concept study in eight patients with AD, which showed promising results. Treatment with LD IL-2 significantly expanded Treg (regulatory T cell) population and function. Cognitive function also improved, as measured by the MMSE score. The treatment was well-tolerated, with mild injection-site reactions and leukopenia being the most common adverse events.

Howard Berman, CEO of Coya Therapeutics, expressed optimism about the potential of LD IL-2 as a therapy for Alzheimer’s Disease. Positive results from this phase 2 trial could lead to further development and exploration of LD IL-2 as a monotherapy or in combination with other approved treatments.

Alzheimer’s Disease is the most common cause of dementia, affecting millions of Americans. It is a progressive disease that gradually worsens cognitive abilities and memory. Coya Therapeutics is focused on developing treatments that target systemic inflammation and neuroinflammation by enhancing the function of regulatory T cells.

For more information about Coya Therapeutics and its product candidates, visit their website at www.coyatherapeutics.com.