The clinical trial is designed to evaluate the safety, tolerability and efficacy of AT-1001 in 86 subjects during gluten challenge. Patients were randomized into seven drug-treated and placebo groups and challenged three times a day with gluten for a 14-day period.
Celiac disease is a T-cell mediated auto-immune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten.
The only current treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients.