Biomarkers

Objective: Identify and evaluate new biological markers of therapeutic efficacy in chronic Chagas disease.

There is no single reliable test of cure that can be used to monitor the efficacy of a treatment in chronic Chagas disease patients in a timely manner. The lack of validated early markers of parasitological cure poses a significant hurdle for the development and regulatory approval of new drugs. Current work is focused on raising awareness among Chagas stakeholders about the need for biomarkers, with particular emphasis on regulatory aspects and the biomarker development process. The potential of the MultiCruzi assay is being further refined and assessed in adults for its ability to predict cure quicker than conventional serology.

The analysis of a multicentre study carried out by NHEPACHA, an Ibero-American network of researchers working on Chagas, highlighted the need for further studies to identify more appropriate tools for early assessment of therapeutic outcomes in Chagas disease.

In 2023, Analysis of samples from the BENDITA and E1224 clinical trials using the MultiCruzi assay yielded promising outcomes. After relatively brief post-treatment monitoring periods as compared with conventional ELISA testing, the MultiCruzi assay allowed for quantification of the degree of seroreduction and thus predict future seroreversion as a surrogate marker of parasitological cure for patients with Chagas disease. Antibody decline in samples from the studies’ treatment arms was significantly faster than in the placebo arms, and a dynamic and sustained response to treatment was observed between 6 and 12 months’ follow-up. Results are pending an analysis of the same samples conducted by CONICET in Argentina to assess the inter-laboratory reproducibility of the technique.