Coya Therapeutics, Inc., a biotechnology company in the clinical stage, recently completed a Phase 2 study of LD IL-2 in patients with mild-to-moderate Alzheimer's disease. Led by Drs. Stanley Appel and Alireza Faridar at Houston Methodist Hospital, the study, funded by the Gates Foundation and the Alzheimer’s Association, is expected to report its top-line results during the summer of 2024.

This Phase 2 study evaluates the safety, tolerability, and biological activity of LD IL-2 compared to a placebo over specific intervals in AD patients. It also examines blood and cerebrospinal fluid biomarkers, neuroimaging results, and changes in cognitive function across different patient groups.

Coya Therapeutics, stated, “This study marks a significant step forward in our efforts to broaden our dementia-focused pipeline. We eagerly anticipate unveiling the findings from this controlled examination in Alzheimer’s Disease later this summer.”

In this study, 38 patients were randomly assigned to receive commercial subcutaneous LD IL-2 at two different dosing schedules or a matching placebo over a 21-week period, followed by a 9-week follow-up post-treatment. The first patient group received LD IL-2 for five consecutive days every four weeks, while the second group received LD IL-2 for five consecutive days every two weeks.

Previously, Coya reported positive outcomes from an open-label proof-of-concept study involving eight AD patients, where treatment with LD IL-2 notably expanded Treg population and function. Cognitive function evaluation demonstrated a significant improvement in mean Mini-Mental State Examination (MMSE) scores during the treatment phase. Additionally, there was no significant change in mean scores on ADAS-Cog and CDR-SB scales, indicating no cognitive decline compared to pre-treatment baseline scores.

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

Alzheimer's disease is the leading cause of dementia, characterized by memory loss and other cognitive impairments affecting daily life. It affects an estimated 5.7 million Americans, with symptoms typically manifesting after age 60. Alzheimer's is progressive, with symptoms worsening over time, leading to severe cognitive decline.

COYA 302 is an investigational biologic combination therapy designed to enhance regulatory T cell function and suppress inflammation. It consists of proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration to treat ALS, FTD, and PD.

 

Source: businesswire.com

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