Celiac Drug Sees Success in Trial

in Celiac
Published: June 10, 2014

The first pharmaceutical support for the gluten-free diet in celiac patients is making big progress.

Known as larazotide acetate, the emerging drug works by inhibiting a protein called zonulin, which has been shown to increase the permeability of the gut in celiac disease, allowing gluten particles to pass through to trigger inflammation, and gastrointestinal and other symptoms.

At Digestive Disease Week in May 2014, Dr. Joseph Murray of the Mayo Clinic presented results from a major trial, which involved 342 celiac patients at 74 North American sites. Those taking larazotide acetate had significantly fewer gastrointestinal symptoms compared to those taking a placebo. Other symptoms, such as headache and tiredness, were also markedly reduced.

Larazotide acetate would work as a support to the gluten-free diet. By taking it before a meal, the idea would be to minimize any effects of accidental gluten ingestion. Other research shows that up to 65 percent of those with celiac disease on a gluten-free diet continue to be exposed to gluten.

Murray said the subjects in the drug study “had been on a gluten-free diet for a median of five years, so the disease and its treatment were stable. We wanted a real-life setting to evaluate this drug as an adjunct to a gluten-free diet.”

The next step forward is a larger trial. The medication has been granted ‘fast track’ status by the FDA and, provided the next results are strong as well, this could help bring larazotide acetate to market faster.