Medical Innovations

E40, a novel glutenase to break down partially digested gluten

Gluten is a complex group of proteins found in barley, wheat, and rye, that is only partially digested by the human digestive enzymes in the gastrointestinal tract, resulting in the release of immunogenic peptides that can cause immuno-toxicity to the intestinal mucosa. In Wheat, these immunogenic fragments include gliadins (of which α-gliadin is the most immunogenic) and glutenins.

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

Currently the only available treatment for CeD is a strict lifelong adherence to a GFD.

NCGS sufferers may find relief from gluten exclusion or a GFD as well.

However, gluten is present in many different foods as well as remaining present, albeit in small amounts (<5ppm) in a gluten ‘free’ diet, so following a strict and truly gluten free diet is difficult. Symptoms can be easily triggered by inadvertent exposure to 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 3,000 mg/day, depending on how strict the sufferer is, and about 50% of celiac patients following a strict GFD continue to suffer from a variety of symptoms, including due to inadvertent exposure episodes.

E40 is our proprietary oral enzyme for safely and effectively breaking down gluten, minimising any immunogenic fragments exiting the stomach and continuing to provide protection in the small intestine. E40 safely and effectively breaks down all 6 immunotoxic epitopes (part of an antigen that is recognized by the patients’ immune system) of α-gliadin in the stomach with ongoing protection in the small intestine, protecting patients from symptomatic inadvertent gluten exposure.

E40 is produced under GMP conditions through recombinant technology. It is resistant to gastric acidity and to gastrointestinal digestive enzymes allowing it to be fully effective in the stomach and retaining activity in the small intestine for continued protection.