The current standard of care for celiac disease patients is a gluten-free diet (GFD); however, 60% or more of patients on a GFD may continue to have persistent symptoms related to celiac disease and the ingestion of gluten. In addition, the majority of patients who are in clinical remission and claim to be following a GFD, have persistent inflammation in the small bowel. Unless complete gluten exclusion is strictly followed, patients may have increased risk for developing further complications such as osteoporosis, neurologic diseases, liver diseases, malignancies, and increased mortality. Total exclusion of dietary gluten is difficult because gluten is one of the most common food ingredients. Market research indicates that celiac disease patients find it hard to identify gluten-free food and follow a complete gluten-free diet. Even motivated patients who attempt to adhere to the diet are affected due to inadvertent or background exposure to gluten. Celiac disease adversely affects quality of life (by decreasing ability to travel, and eat out, etc). There is an acute need for non-dietary therapies for celiac disease.
The North American and E.U. celiac disease prevalence is approximately 1%-2% of the population with only an estimated 10% -20% to 25% of patients diagnosed, respectively. There are close to 1 million patients who are diagnosed and follow a gluten-free diet in the U.S. and E.U. The National Foundation for Celiac Awareness estimates that 500,000 new patients will be diagnosed with celiac disease over the next 5 years.