A majority of individuals with CD do not recover well under a GFD. Furthermore, there is still no effective means for monitoring the intestinal health of a recovering celiac other than an invasive biopsy and even that method is prone to interpretive analysis. This problem is particularly acute in the United States where recent studies have shown that more than 50% of adult celiac patients have persistent villous atrophy.

For disease management we are currently in a clinical study for a metabolic marker compound that can measure the state of recovery of a celiac patient undergoing a GFD. This study follows a very successful proof of concept trial. This is a unique capability for which there are no other effective diagnostics.

In this test (referred to as CypCel), a single oral dose of the widely used cholesterol-lowering agent, simvastatin (SV), is administered to a patient. The serum concentration of SV is then measured as an indicator of the health of the intestinal epithelium resulting from adherence to a GFD. CypCel is based on the insight that SV is principally metabolized by cytochrome P450 monooxygenase 3A4 (CYP3A4) in the small intestinal epithelium.

Because intestinal inflammation results in reduced CYP3A4 activity in the epithelium, the serum concentration of SV correlates with the recovery of a CD patient. A preliminary clinical study in CD patients demonstrated the proof of concept that CypCel was markedly more effective at detecting subclinical disease in treated CD patients than other serum markers that have been investigated in recent years, including anti-TG2 IgA, anti-DGP IgA, and intestinal fatty acid binding protein (I-FABP) (Moron 2013). CypCel has potentially huge implications for post-diagnostic management of CD for which methods do not currently exist.