For people with celiac disease, gluten enemy #1. For some celiac patients, an exposure to gluten can make them sick for days with pain, vomiting and diarrhea while causing intestinal damage. And, maintaining a 100% gluten free diet can be challenging, creating a great need for therapeutics to help keep the body free of gluten, even if a mistake happens.
An experimental new drug may provide relief to celiac disease patients who happen to ingest gluten. At the upcoming Digestive Disease Week (DDW) conference, the findings of a phase 2 study of a drug will be discussed. The drug, called AMG 714 antibody, leads to fewer symptoms after gluten exposure by blocking interleukin 15. A randomized, double-blind, placebo-controlled, phase 2 study was conducted to test the drugs effectiveness. It was compared to a placebo in celiac disease patients over a 12-week period.
A subset of patients received a high-dose gluten challenge of approximately 2.5 grams per day for 10 weeks. Another sub-group of patients were exposed to hidden gluten contamination during their regular gluten-free diets and did not receive the additional gluten challenge. The amount of gluten that slips, unknowingly, into the gluten free diets of celiac disease patients is being appreciated more now than ever. But, that is exactly where this drug may play a role. It is not designed to be taken and then sit down to a gluten-filled pasta meal. Rather, it is for the small amounts of gluten that slips in. The gluten contamination can occur during food processing, packaging, cooking or in labeling errors.
The study showed that the AMG 714 had an effect on the groups of participants who received the drug and the gluten challenge when compared to the placebo group who received no drug. Both a reduction in reported symptoms occurred as well as a decrease in injury to the intestinal lining. Also, the drug appears to be safe as there were no concerns in the groups of people who received the drug.
As of right now, the only treatment for people with celiac disease has been to maintain a gluten free diet. However, that is at best challenging and at worst almost impossible, depending on the living circumstances. Therefore, new therapeutics are critical to giving the celiac disease community more weapons in their arsenal. Therefore, something like AMG 714 might be a much needed addition to a strict diet, to help keep celiac disease patients healthy.