Conference Coverage

Experimental drug may help those living with celiac disease



A new, experimental drug may offer a treatment option for celiac disease patients following a gluten-free diet who are inadvertently exposed to gluten.

“Contamination with gluten happens during food processing, food packaging, cooking, and [because of] inadequate labeling,” Francisco Leon, MD, a consultant for Amgen and former CEO of Celimmune, said in a media briefing in advance of the annual Digestive Disease Week® (DDW). “Gluten is [also] present in unsuspected places like lipstick, toothpaste, even medicines. It is virtually impossible for celiac patients to completely avoid gluten.”

The new drug, AMG 714, works by blocking interleukin 15, a known intestinal inflammatory mediator, and lowers inflammation, resulting in fewer symptoms for patients.

In a 12-week study, patients received either 150- or 300-mg doses of subcutaneous AMG 714, or placebo. All doses of AMG 714 were administered six times over the course of the study. From weeks 2 to 12, patients were challenged with a daily dose of 2.5 grams of gluten, which is considered a high dose.

The results showed that AMG 714 significantly reduced Celiac Disease Patient Reported Outcomes at the 300-mg dose (P = .02) compared with placebo. Similarly, AMG 714 decreased Celiac Disease Gastrointestinal Symptom Rating Scale scores at the 150-mg (P = .17) and 300-mg (P = .07) doses, compared with placebo.

Dr. Leon noted that there was another subset of patients who did not receive the gluten challenge because they were shown to have intestinal atrophy – marked by the presence of flat mucosa – because of contamination in their gluten-free diets. This was measured by way of a novel stool and urine detection test. This information will be presented at DDW.

AMG 714 also improved gluten-triggered diarrhea and physician assessments, according to Dr. Leon. In fact, using the Bristol Stool Form Scale, patients who received both the 150-mg (P = .01) and 300-mg (P = .0002) doses had substantially lower rates of diarrhea, compared with placebo.

These positive results were not isolated to the Bristol Stool Form Scale scores, but extended to the Physician Global Assessment as well.

“The proportion of subjects whom physicians evaluated as clinically active at week 12 was 0 in the high dose of AMG 714 while it was 33% in the placebo group,” stated Dr. Leon.

While AMG 714 has shown promise in alleviating celiac disease symptoms for patients inadvertently exposed to gluten, it is not intended to treat exposure to high amounts of gluten.

“It is important to note that AMG 714 is intended to protect against modest contamination [with] gluten and not against the effects of regularly eaten large amounts of gluten, like bread or pasta,” Dr. Leon cautioned. “But we know that people with celiac disease are inadvertently exposed to gluten. So it is our hope that AMG 714 will allow these patients to experience fewer gluten-triggered events.”

The information presented by Dr. Leon was only a taste of what will be presented at DDW®.

“At DDW, we will show you a reduction in inflammation, and we will also show you the safety profile. There were no serious adverse events.

“We are hopeful that this will become one of the tools to combat celiac disease.”

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