Alvine Pharmaceuticals has dosed the first randomized study patient in the CeliAction Study, a Phase IIb study of its lead clinical candidate, ALV003, which is in development for the treatment of patients with celiac disease. ALV003 is an orally administered mixture of two gluten-specific proteases shown in vitro to degrade gluten, the primary immunologic trigger for celiac disease.

The CeliAction Study will evaluate the safety and efficacy of ALV003 at different dose levels administered during a 12-week period in approximately 500 patients in the U.S., Canada and Europe. The study is currently enrolling diagnosed celiac disease patients who are symptomatic despite attempting to follow a gluten-free diet; patients must remain on a gluten-free diet during the study.

The primary efficacy endpoint for the study is the change in small intestinal mucosal morphology as measured by the change in villus height to crypt depth ratio (Vh:Cd) from baseline and week 12 assessments. Secondary endpoints are the changes in density in intestinal intraepithelial lymphocytes and celiac disease-specific symptoms during the study. Other outcomes to be evaluated include changes in celiac disease serologies and quality-of-life measures. Approximately 120 patients will be allowed to stay on study treatment for an additional 12 weeks to continue measuring efficacy and safety.