Patent ID: 8535946
Filing Date: 2013-09-17
Classification: A61K,G01N,Y10T

Abstract:
1. A non-invasive method for assessing the efficacy of a clinical regimen in the treatment of an individual with an intolerance to gluten, the method comprising: identifying an individual as having an intolerance to gluten undergoing treatment with a clinical regimen of interest; administering an oral dose of a CYP3A substrate to the individual, quantitating a post dose concentration of the CYP3A substrate and/or its metabolite(s) in at least one sample from the individual, selected from the group consisting of blood, saliva, urine and breath; assessing efficacy of the regimen, wherein an efficacious regimen protects from gluten-induced enteropathy that results in decreased enteric metabolism of the CYP3A substrate relative to a gluten-tolerant control sample, to generate an analysis of efficacy; and providing the analysis of the efficacy of the clinical regimen, wherein the extent of metabolism of the CYP3A substrate to its metabolite, indicated by said post-dose concentration, is a non-invasive surrogate for the efficacy of the clinical regimen in protecting the individual from gluten-induced enteropathy.