A new drug being developed for people with celiac disease has shown promising early results in protecting the small intestine from gluten-related damage, according to preliminary clinical trial findings.
The drug, ANB033, was tested in a small early-stage trial involving 32 patients who had been diagnosed with celiac disease at least one year earlier. Participants were following a gluten-free diet but had already been found to have moderate intestinal damage through biopsies.
Trial Tested Response to Gluten Exposure
During the study, participants received three injections of either ANB033 or a placebo at the beginning of the trial and during the second and fourth weeks. They were then asked to consume 6 grams of gluten daily for two weeks, roughly equivalent to the amount found in two slices of bread.
Biopsies taken at the end of the study showed that patients who received ANB033 had statistically significant protection against gluten-related intestinal damage compared with those who received the placebo, according to the company developing the drug.
The study also found that symptoms did not increase significantly among patients receiving ANB033 during the gluten-exposure period, while the placebo group experienced a notable increase in symptoms.
What Is Celiac Disease?
Celiac disease is an immune-mediated condition in which the body reacts abnormally to gluten, a protein found mainly in wheat, barley and rye. Gluten exposure can trigger inflammation and damage to the lining of the small intestine.
Even small amounts of gluten can cause symptoms and intestinal damage in people with celiac disease, making strict avoidance of gluten the mainstay of current management.
Fewer Patients Needed Additional Medication
The study reported that only 6% of patients receiving ANB033 required permitted additional medication to manage gastrointestinal symptoms, compared with 47% of those in the placebo group.
Researchers say ANB033 works by targeting the activity of two immune-related proteins, IL-15 and IL-2, which are involved in inflammatory processes associated with intestinal damage in celiac disease.
Larger Studies Still Needed
ANB033 remains in the early stages of clinical development. The findings come from a small study, and larger trials will be needed to determine the drug’s effectiveness and long-term safety.
The preliminary results therefore do not establish ANB033 as an approved treatment for celiac disease, but they provide early evidence that the drug may help protect the intestine during accidental or controlled gluten exposure.