Alvine Pharmaceuticals, Inc. today announced that patient enrollment has begun in a Phase 2a, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ALV003 for use in the treatment of celiac disease.
“The commencement of this Phase 2a study is an exciting milestone in the clinical development of ALV003 as a potential therapeutic option for patients with celiac disease,” said Daniel C. Adelman, M.D., Alvine’s Senior Vice President of Development and Chief Medical Officer.
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. Approximately 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.
“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,” said Dr. Adelman. Results are expected in the second half of 2010.
“The only option that celiac disease patients have today is adherence to a gluten free diet, which does not fully eliminate symptoms and complications. We are hopeful that ALV003 will show significant potential to improve the lives of patients with celiac disease,” said Dr. Markku Mäki, Professor of Pediatrics at the University of Tampere, Tampere, Finland.