Hepcidin is the peptide hormone responsible for regulating circulating iron concentrations. Overexpression of hepcidin results in severe iron deficiency and anemia, whereas hepcidin deficiency leads to iron overload. Not surprisingly, abnormalities in hepcidin production and circulating concentrations are highly correlated with various disease states such as renal disease, cancer, hereditary hemochromatosis (HH), hypoxia, anemia of inflammation, infection, inflammatory diseases, and heart disease. Accurate methods for detecting hepcidin in serum will lead to improvements in our understanding, diagnosis, and clinical management of iron metabolism disorders. Unfortunately, there is no FDA approved assay for measuring hepcidin levels in serum. The development of a clinically relevant hepcidin assay has been hindered by hepcidin's very low immunogenicity, making it extremely challenging to produce antibodies against the hormone. The few immunoassays that do exist are poorly characterized in terms of specificity, and they struggle to differentiate hepcidin from the multiple inactive forms of the hormone that are found in the circulation. Affinergy will overcome these problems by using phage display biopanning to identify highly specific hepcidin-binding peptides. A peptide-based assay will circumvent the many challenges and limitations associated with the more traditional immunoassay approach, allowing us to accelerate the development of a clinically relevant hepcidin assay that will address a significant unmet need with the potential for widespread adoption.

Public Health Relevance

Hepcidin is the peptide hormone responsible for regulating circulating iron concentrations, and abnormalities in hepcidin production and circulating concentrations are highly correlated with multiple disease states. Unfortunately, hepcidin has a very low immunogenicity, making it extremely challenging to develop antibodies and immunoassays for the hormone. In this application, we propose to use phage display biopanning to identify hepcidin-binding peptides and begin development of a clinically relevant assay for measuring serum hepcidin levels.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DK101264-01
Application #
8647340
Study Section
Special Emphasis Panel (ZRG1-IMST-L (11))
Program Officer
Bishop, Terry Rogers
Project Start
2014-09-03
Project End
2015-08-31
Budget Start
2014-09-03
Budget End
2015-08-31
Support Year
1
Fiscal Year
2014
Total Cost
$276,193
Indirect Cost
Name
Affinergy,Inc
Department
Type
DUNS #
City
Research Triangle Park
State
NC
Country
United States
Zip Code
27709