The effects of ALV003 pre-digestion of gluten on immune response and symptoms in celiac disease in vivo

Effective treatment of celiac disease is an unmet medical need. A glutenase that destroys immunogenic gluten peptides may be clinically valuable. Twenty patients with celiac disease were randomly assigned to ingest a large gluten meat (16 g daily for 3 days) pre-treated with ALV003, a mixture of highly specific glutenases (n = 10), or pre-treated with placebo (n = 10). Peripheral blood T-cell. IFN-gamma ELISpot responses to gliadin and an immunogenic 33mer and symptoms were assessed. While baseline IFN-gamma ELISpot responses to ghadin and the 33mer were negative in all patients, a significant ELISpot response to gliadin or the 33mer was observed in 6 of 10 patients consuming ptacebo-treated gluten and 0 of 10 consuming ALV003 pre-treated gluten (p=0.011). Symptoms typically associated with gluten ingestion occurred in both groups and were not significantly reduced by ALV003 pre-treatment. ALV003 pre-treatment can abolish immune responses induced by gluten in patients with celiac disease. (C) 2009 Elsevier Inc. All rights reserved.