- Wednesday, October 16, 2024
Coya Therapeutics announced encouraging findings from an open-label proof-of-concept clinical study investigating the use of ld IL-2 in patients with Alzheimer's disease.
Study Details
The study included eight patients who had confirmed brain amyloid pathology and baseline Mini-Mental State Examination (MMSE) scores between 12 and 25.
During the trial, patients received five-day courses of subcutaneous treatment with ld IL-2 for four monthly cycles. Following treatment, patients were monitored for an additional two months. Throughout the study, various factors were assessed, including Treg function and numbers, serum biomarkers of inflammation, safety and tolerability, and cognitive functioning.
Promising Results
An evaluation of cognitive function revealed a statistically significant improvement in mean MMSE scores during the treatment phase when compared to baseline scores. This suggests that the administration of ld IL-2 positively impacted cognitive abilities in patients with Alzheimer's disease.
Safety and Tolerability
The administration of ld IL-2 was found to be safe and well tolerated by the patients. The most common adverse events reported were mild injection-site reactions and mild leukopenia. No serious adverse events occurred, and no patients discontinued the study due to adverse effects.
Future Research
A Phase 2 study involving 46 patients with mild-to-moderate Alzheimer's disease is currently being carried out at Houston Methodist Hospital. The study aims to evaluate the safety and tolerability of two dose regimens of ld IL-2 over a 30-week period. Additionally, Treg function, blood biomarkers of neuroinflammation, and overall efficacy will be assessed. Top-line results from this study are expected to be released in July 2024.
These promising results indicate Coya Therapeutics' dedication to finding innovative treatment options for Alzheimer's disease.
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