Alvine has initiated patient enrollment in a phase 2a, randomized, double-blind, placebo-controlled study, to assess the safety and efficacy of ALV003 for the treatment of celiac disease.
The objective of the study is to assess the potential for patient benefit and gather safety data regarding repeat dosing with ALV003, as well as to evaluate potential endpoints for use in subsequent phase 2b and 3 studies.
Reportedly, about 110 patients with well-controlled celiac disease will be randomized to receive either daily ALV003 or placebo for six weeks, with a 28 day post-treatment follow-up.
Daniel Adelman, senior vice president of development and CMO at Alvine, said: “This study is designed to assess the ability of ALV003 to prevent gluten-induced mucosal injury caused by the gluten that could contaminate an attempted gluten-free diet, by evaluating changes in intestinal histology, serology and symptoms. We expect the trial will yield important information on the safety and potential efficacy of ALV003.”