Coya Therapeutics has reported results from a proof-of-concept clinical study of low-dose interleukin 2 (ld IL-2) for the treatment of patients with Alzheimer’s disease (AD).

Conducted at the Houston Methodist Hospital in the US, the open-label study assessed the tolerability, safety, biological activity, blood biomarkers, and preliminary efficacy of ld IL-2 in eight patients with AD.

Patients with a confirmed presence of brain amyloid pathology and baseline mini-mental state examination (MMSE) test scores between 12 and 25 were enrolled in the study.

They received five-day courses of a subcutaneous dosage of ld IL-2 for four monthly cycles. and were then followed for two months after completion of the treatment.

Using the Clinical Dementia Rating-Sum of Boxes scale (CDR-SB), various parameters including tolerability, safety, cognitive functioning, serum biomarkers of inflammation, and T reg function and numbers were measured.

Assessment tools such as the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) and MMSE were also used to assess the parameters.

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The additional clinical data also demonstrated a significant decrease in biomarker levels associated with neuroinflammation in patients with AD, further supporting the study’s initial positive data.

ld IL-2 showed biological activity by restoring peripheral regulatory T cell (Treg) function and numbers.

It also significantly reduced blood levels of interleukin 15, monocyte chemoattractant protein-1, and CC motif chemokine ligand 11.

Coya is also conducting a Phase II double-blind, placebo-controlled study in nearly 46 patients with mild-to-moderate AD. It will assess the efficacy of two doses of ld IL-2 against a placebo over a 30-week period.

Top-line results from the Phase II study, funded by the Gates Foundation and the Alzheimer’s Association, are anticipated in July next year.