1022moleculeThe Market – Disease Therapy

Unmet Need

The current standard of care for celiac disease patients is a gluten-free diet (GFD); however, over 60% 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. 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.


The North American and European celiac disease prevalence is approximately 1%-2% of the population with only about 10% -20% and 25%, respectively, of patients diagnosed. There are over 1 million patients who are diagnosed and follow a gluten-free diet in the U.S. and Europe. The patient advocacy group Beyond Celiac estimates that 500,000 new patients will be diagnosed with celiac disease over the next 5 years.

The market for addressing the needs of this population of diagnosed and diligent patients to help protect against the inevitable intrusion of gluten is considerable.

Mission and Values

ImmunogenX is proud to carry on the pioneering work of Alvine Pharmaceuticals and to continue to apply our passion and dedication on the integrity, scientific excellence, and understanding of celiac disease. This passion is borne of key members of ImmunogenX suffering from celiac disease and dedicating their professional careers to developing innovative therapeutic and diagnostic products to improve the lives of celiac patients. IMGX003 has been issued Fast Track designation by the FDA for having developed an effective and safe drug that meets a critical unmet need. IMGX003 is the only CD treatment thus far that has been shown to mitigate gluten-induced intestinal mucosal injury as well as evidence symptomatic improvements in clinical trials.