Novel Drug for Celiac Disease Shows Promise
(HealthDay News) — Larazotide acetate 0.5mg is associated with improvement in symptoms of celiac disease (CeD), according to a study published in the June issue of Gastroenterology.
Daniel A. Leffler, PhD, from Beth Israel Deaconess Medical Center in Boston, and colleagues conducted a multicenter, randomized trial assessing larazotide acetate 0.5, 1, or 2mg three times daily to relieve symptoms of CeD. Three hundred forty-two adults with CeD who had been on a gluten-free diet for ≥12 months were included in the study. The difference in average on-treatment Celiac Disease Gastrointestinal Symptom Rating Scale score was assessed as the primary end point.
The researchers found that the primary end point was met with the 0.5mg dose of larazotide acetate, with fewer symptoms vs. placebo in modified intent-to-treat analysis (340 patients). The 0.5mg dose affected exploratory end points such as a decrease in CeD patient-reported outcome symptomatic days (26% decrease; P=0.017); increase in improved symptom days (31% increase; P=0.034); ≥50% reduction from baseline of the weekly average abdominal pain score for six or more of 12 weeks of treatment (P=0.022); and reduction in nongastrointestinal symptoms of headache and tiredness (P=0.010). No differences were seen for 1- and 2-mg doses vs. placebo.
"Larazotide acetate 0.5mg reduced signs and symptoms in CeD patients on a gluten-free diet better than a gluten-free diet alone," the authors write.
Several authors disclosed financial ties to pharmaceutical and biotechnology companies, including Alba Therapeutics Corporation and Cephalon/Teva, both of which provided funding for the study.