Medical Innovations

E40, a novel glutenase to break down partially digested glutens

Gluten is a complex group of proteins found in barley, wheat, and rye, which is only partially digested by the digestive enzymes in the stomach, so it releases immunogenic peptides, resulting immuno-toxicity to the intestinal mucosa.  These immunogenic fragments include Gliadins (of which α-gliadin is the most immunogenic) and Glutenins.

Gluten Intolerance in Celiac Disease (GD) and Gluten Sensitivity in Non Celiac Gluten Sensitivity (NCGS) pose unmet clinical needs, even for subjects following a Gluten-Free Diet.

Currently the only available treatment for CD is a strict lifelong gluten-free diet.

NCGS patients may find relief from a gluten-exclusion or gluten-free diet (GFD) as well.  However, gluten is present in many different foods, so following a strict gluten-free diet is difficult. Symptoms can be easily triggered by inadvertent exposure of gluten, such as when dining out. In fact, even with a Gluten Free Diet, unintentional intake of gluten can range from 200 mg/day to up to 3000 mg/day, depending on how strict that patient is, and about 50% of celiac patients following a GFD continue to suffer from a variety of symptoms probably due to inadvertent exposure.

E40, is an oral enzyme effectively breaking down gluten even in absence of pepsin, with no immunogenic fragments exiting the stomach after E40 digestion.  It effectively breaks down all the 6 immunotoxic epitopes (part of an antigen that is recognized by the patients’ immune system) of α-gliadin in the stomach.  E40 was originally discovered in soil actinomycete Actinomallurus species and is now produced through recombinant technology. It is resistant to gastric acidity and to gastro intestinal digestive enzymes. E40 maintains up to 50% of its activity in the small intestines.