Coya Therapeutics has announced the conclusion of a Phase II clinical trial investigating low-dose interleukin-2 (LD IL-2) for the treatment of mild-to-moderate Alzheimer's disease (AD).

Supported by the Gates Foundation and the Alzheimer's Association, the randomised, double-blind, placebo-controlled controlled study is being conducted at Houston Methodist Hospital in the US.

The study is aimed at assessing the safety, tolerability, and biological activity of LD IL-2 in mild-to-moderate AD patients.

It will also assess the effects of LD IL-2 on blood and cerebrospinal fluid biomarkers, neuroimaging data, and changes in cognitive function.

The study involved 38 AD patients who were given either LD IL-2 or a placebo over 21 weeks, followed by a nine-week follow-up.

Topline results from the trial are expected to be reported in the third quarter of this year.

Previous findings from an open-label, proof-of-concept study indicated that LD IL-2 treatment significantly expanded the regulatory T cell (Treg) population and function in eight AD patients.

The mean (SD) percentage of Tregs rose to 8.68 at the end of treatment from 4.55 at baseline.

Additionally, the same study showed a significant improvement in Mini-Mental State Examination scores during the treatment phase.

The LD IL-2 treatment was found to be well-tolerated, with the most common adverse events being mild injection-site reactions and leukopenia.

No serious adverse events or patient discontinuations were reported in the study.

Coya Therapeutics president and CMO Fred Grossman said: “This is an important study that will help advance our expanding pipeline in dementia.

“We look forward to unblinding the data from this controlled study in Alzheimer’s disease and releasing the top-line results this summer.”