Unmet Need

The current standard of care for celiac disease patients is a gluten-free diet (GFD); however, a majority of patients following a GFD 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 (as evidence by negative celiac antibody tests) while following a GFD, have persistent inflammation in the small bowel (Lee 2003). Unless complete gluten exclusion is strictly followed, patients continue to be at increased risk for developing further complications such as osteoporosis, neurologic diseases, liver diseases, malignancies, and increased overall mortality. Total exclusion of dietary gluten is difficult because gluten is one of the most common food ingredients. Patients with celiac disease find it hard to identify truly 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.

Lee SK, Lo W, Memeo L et al. Duodenal histology in patients with celiac disease after treatment with a gluten-free diet. Gastrointest Endosc 2003; 57: 187–91.


The North American and European celiac disease prevalence is approximately 1% of the population. In the U.S. the diagnosis rate has increased dramatically in just the last 6 years as shown below. Europe is even more diligent about properly diagnosing CD. Consequently, there are now nearly 3 million patients who are diagnosed and follow a gluten-free diet in the U.S. and Europe (Rubio-Tapia 2012, Singh 2018, Choung 2017). The patient advocacy group Beyond Celiac estimates that 500,000 new patients will be diagnosed with celiac disease over the next 5 years.


Rubio-Tapia A, Ludigsson JF, Brantner TL, Murray JA, Everhart JE. The prevalence of celiac disease in the United States. Am J of Gastroenterol 2012;107:1538-1544.

Singh P, Arora A, Strand TA, Leffler DA, et al. Global prevalence of celiac disease: Systematic review and meta-analysis. Clin Gstroenterol Hepatol 2018; S1542-3565(17)30783-8.

Choung RS, Larson SA, Khaleghi S, Rubio-Tapia A. Prevalence and morbidity of undiagnosed celiac disease from a community-based study. Gastroenterol 2017;152:830-839.