Atypical hemolytic uremic syndrome (aHUS) biomarker proteins
AssigneeAlexion Pharmaceuticals, Inc.
InventorsSusan Faas McKnight, Roxanne Cofiell, Anjli Kukreja, Krystin A. Bedard, Yan Yan
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AssigneeAlexion Pharmaceuticals, Inc.
InventorsSusan Faas McKnight, Roxanne Cofiell, Anjli Kukreja, Krystin A. Bedard, Yan Yan
Estimating the term…
The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.
A method for monitoring responsiveness of a subject to treatment with an inhibitor of complement C5, the method comprising:
The method of 1, wherein the complement C5 inhibitor is selected from the group consisting of a small molecule, a polypeptide, a polypeptide analog, a peptidomimetic, and an aptamer.
The method of 1, wherein the complement C5 inhibitor is selected from the group consisting of MB12/22, MB12/22-RGD, ARC187, ARC1905, SSL7, and OmCI.
A method for diagnosing a subject as having or being at risk for developing atypical hemolytic uremic syndrome (aHUS), the method comprising:
A kit for diagnosing aHUS, wherein the kit comprises (a) an assay plate and (b) at least three binding agents, wherein the binding agent is an antibody, or an antigen-binding fragment thereof, capable of binding to a different biological analyte, wherein the analytes are proteins, wherein the proteins are selected from the group consisting of TNFR-1, a proteolytic fragment of complement component factor B, soluble C5b9 (sC5b9), thrombomodulin, VCAM-1, von Willebrand Factor (vWF), soluble CD40 ligand (sCD40L), prothrombin fragment F1+2, D-dimer, MCP-1, TNFR1, IFN-γ, ICAM-1, IL-1 beta, IL-12 p70, complement component C5a, β2 microglobulin (β2M), clusterin, cystatin C, NAG, TIMP-1, NGAL, fatty acid binding protein 1 (FABP-1), CXCL9, KIM-1, IL-18, vascular endothelial cell growth factor (VEGF), IL-6, albumin, IL-8 and CCL5.
Dependencies are inferred from the claim text.