(TiBine, Pixabay)
5 May 2016. A clinical trial testing an engineered antibody therapy for celiac disease in people that do not respond to a gluten-free diet began treating its first patients. The trial is conducted by Celimmune LLC, a biopharmaceutical company in in Lebanon, New Jersey, but patients are recruited in Finland, where the rate of celiac disease is among the highest in the world.
Celiac disease is an inherited immune-system disorder where people cannot tolerate gluten, a protein found in wheat, rye, barley, and some other substances. The immune reaction to gluten causes inflammation in the lining of the small intestine, which prevents absorption of nutrients. Without treatment, inflammation from celiac disease can lead to long-lasting damage in the small intestine, as well as malnutrition, since needed nutrients are not being taken into the body. About 1 percent of the U.S. population has celiac disease.
In an intermediate-stage clinical trial, Celimmune is testing its experimental treatment code-named AMG 714, an engineered antibody designed specifically to block the actions of interleukin-15, a protein produced in immune-system and intestinal cells. Interleukin-15 is associated with activating lymphocytes, white blood cells in the immune system, that destroy mucous membranes in the intestines. The company is commercializing AMG 714 under an exclusive license from the biopharmaceutical company Amgen.
Celimmune is developing AMG 714 as a treatment for people with advanced or specialized cases of celiac disease that do not respond to a gluten-free diet. The company cites data showing at least half of people with celiac disease still suffer symptoms of the disease, even when they avoid food with gluten. The condition is believed to be caused by a heightened sensitivity to gluten, which in many cases is difficult to avoid, even in trace amounts from unlikely sources such as toothpaste.
About 1 in 200 people with the condition contract refractory celiac disease or RCD-II, a complication where malignant lymphocytes are scattered throughout the small intestinal lining, causing chronic diarrhea and lymphoma. Because the cells causing the disorder are scattered through the small intestine, it is difficult to treat and often has a poor prognosis.
The clinical trial is recruiting 63 participants at 3 sites in Finland, with celiac disease and on a gluten-free diet for at least 12 months. Participants will be randomly assigned to receive either AMG 714 or a placebo, and exposed to gluten for 12 weeks. The main effectiveness measure is the change in the state of injuries in the lining of the small intestine among participants at the start of the treatments and after 12 weeks.
Researchers will also look for inflammation in the small intestine, presence of peptide or antibody biomarkers of autoimmune conditions, and other gastrointestinal symptoms. Safety and tolerability of AMG 714 treatments will be assessed as well.
Celimmune says AMG 714 was tested in 4 other trials, and found safe and well-tolerated by healthy volunteers and among people with the autoimmune disorders rheumatoid arthritis or psoriasis. A separate clinical trial is testing AMG 714 among patients with RCD-II.
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