Coya Therapeutics Completes Phase 2 Study of Low Dose IL-2 in Alzheimer’s Patients

Coya Therapeutics, Inc., a clinical-stage biotechnology company, has successfully completed a Phase 2 study evaluating the use of low dose interleukin-2 (LD IL-2) in patients with mild-to-moderate Alzheimer’s disease (AD). The study, funded by the Gates Foundation and the Alzheimer’s Association, was conducted in a double-blind, placebo-controlled manner at Houston Methodist Hospital under the supervision of Drs. Stanley Appel and Alireza Faridar. Results are expected to be reported in the summer of 2024.

The aim of the Phase 2 study is to assess the safety, tolerability, and biological activity of LD IL-2 compared to a placebo. The study includes evaluations of blood and cerebrospinal fluid biomarkers, neuroimaging results, and cognitive function changes across different patient groups. A total of 38 patients participated, with two dosing regimens of LD IL-2 administered over 21 weeks, followed by a 9-week follow-up period. One cohort received LD IL-2 for five consecutive days every four weeks, while the other received it every two weeks.

Fred Grossman, President and Chief Medical Officer of Coya Therapeutics, emphasized the importance of this study in advancing their pipeline for dementia treatments. He expressed enthusiasm for the upcoming data release in the summer and its potential implications.

Previously, Coya reported positive results from an open-label, proof-of-concept study involving eight AD patients. This study demonstrated that LD IL-2 treatment significantly improved cognitive function and enhanced Regulatory T cell (Treg) numbers and function. The mean percentage of Tregs increased from 4.55% at baseline to 8.68% post-treatment, while Treg suppressive function rose from 46.61% to 79.5%. Cognitive improvements were also observed, with statistically significant increases in scores on the Mini-Mental State Examination (MMSE).

Overall, LD IL-2 was well tolerated in the proof-of-concept study, with the most common adverse events being mild injection-site reactions and mild leukopenia. No serious adverse events were reported, and no patients discontinued the study.

Alzheimer’s disease is the most prevalent cause of dementia, responsible for up to 80% of cases and affecting approximately 5.7 million Americans. The disease predominantly affects those over 60 years old and its incidence doubles every five years beyond age 65. It is a progressive condition, with symptoms worsening over time. In its initial stages, memory loss is mild, but in later stages, patients may lose the ability to converse and respond to their surroundings. Alzheimer’s is a leading cause of death, particularly among older adults, with affected individuals living an average of 4 to 8 years post-diagnosis, though some may live up to 20 years.

Coya Therapeutics continues to develop its investigational product, COYA 302, which combines LD IL-2 with CTLA-4 Ig to enhance Treg function and suppress inflammation. This combination therapy is currently being explored for treating neuroinflammatory diseases such as Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Dementia (FTD), and Parkinson's Disease (PD). Results from a recent study involving ALS patients showed that the therapy was well tolerated and suggested a slowdown in disease progression over a 48-week period.

Based in Houston, Texas, Coya Therapeutics is dedicated to developing treatments that leverage the therapeutic potential of Tregs to address systemic and neuroinflammation. Their pipeline includes various therapeutic modalities aimed at restoring Treg function to treat multiple diseases. COYA 302, their lead investigational product, is designed to provide a dual mechanism of action, enhancing Treg function while reducing inflammation, and is being developed for several neurodegenerative diseases.