Alvine Initiates Enrollment in Phase 2a Clinical Trial of ALV003 for Use in the Treatment of Celiac Disease
SAN CARLOS, CA. - August 25, 2009 - 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.
For more information on Alvine’s Phase 2a trial of ALV003, please visit http://www.clinicaltrials.gov.
About Celiac Disease
Celiac disease is the most common hereditary autoimmune disease with prevalence estimated to be as high as 1-2% in the U.S. and E.U. Intestinal inflammation in celiac disease is triggered by the ingestion of gluten in genetically susceptible individuals. Gluten is a protein found naturally in wheat, rye, and barley, and is one of the most common and nutritionally significant ingredients in the human diet. Patients with celiac disease mount an immune response to gluten and gluten fragments, resulting in systemic immune-mediated damage in the gut and other organs. Gluten ingestion can be associated with symptoms such as nausea, diarrhea, constipation and rash. Complications of celiac disease can include osteoporosis, anemia, dermatitis, weight loss, diabetes, central nervous system conditions including depression, autoimmune diseases and malignancies. The only available option for individuals diagnosed with celiac disease today is a life-long adherence to a strict gluten-free diet, which is difficult to follow.
Alvine Pharmaceuticals, Inc. is a privately held biopharmaceutical company dedicated to developing and commercializing therapeutics for autoimmune/gastrointestinal diseases. Alvine’s lead product candidate, ALV003, is being developed to treat patients with celiac disease. For additional information about the company, please visit http://www.alvinepharma.com.
ALV003 is an orally administered mixture of two recombinant proteases engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues that are common in gluten. ALV003 consists of a glutamine specific cysteine protease (EP-B2) and a proline specific prolyl endopeptidase (PEP).
Kirk Essenmacher M.D., M.B.A.
Phone: (650) 596-2434
Vice President of Marketing, Corporate and Strategic Development