Today, there is no FDA-approved therapy to treat people with celiac disease, which causes significant health problems, and affects an estimated 2.4 million Americans. Celiac disease is currently managed by a gluten-free diet, which is costly and difficult to maintain. Many patients continue to report persistent symptoms despite adhering to a gluten-free diet. Celiac disease can develop at any age and, if left untreated, can lead to additional serious health problems.