Alvine Pharmaceuticals Presents Data on the Effects of ALV003 in a Gastric Model That Predicts In Vivo Activity at DDW 2010
SAN CARLOS, CA. - May 4, 2010 - Alvine Pharmaceuticals, Inc., today announced the reporting of scientific data on the performance of its lead compound, ALV003, in a gastric simulation model. The data were presented at the 2010 Digestive Disease Week (DDW) meeting held in New Orleans, Louisiana. The abstract is available on the DDW web site at http://www.ddw.org.
Alvine’s abstract, entitled: “ALV003, a Mixture of Two Oral Proteases, Degrades Immunogenic Gluten Epitopes in a Complex Food Environment” was presented Sunday, May 2nd, 2010. Alvine scientists reported on a simple gastric digestion model they developed to study the ability of ALV003 to degrade gluten in the context of a complex meal.
“The data derived from the gastric simulation model were consistent with in vivo data from a Phase 1 study, with comparable degrees of gluten degradation observed,” said Daniel C. Adelman, M.D., Alvine’s Senior Vice President of Development and Chief Medical Officer. “These data have been used to inform the design of our ongoing Phase 2a study.”
The current Phase 2a study is double-blind, placebo-controlled and is being conducted in well-controlled celiac disease patients receiving a daily gluten challenge for six weeks.
ALV003 is an orally administered combination 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). ALV003 is being developed by Alvine as a potential treatment for patients with celiac disease.
About Celiac Disease
Celiac disease is the most common hereditary autoimmune disease with prevalence 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, autoimmune diseases, intestinal malignancies, peripheral and central nervous system conditions including depression. 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 as a potential treatment for patients with celiac disease. For additional information about the company, please visit http://www.alvinepharma.com.
Kirk Essenmacher M.D., M.B.A.
Phone: (650) 596-2434
Vice President of Marketing, Corporate and Strategic Development