Alvine Pharmaceuticals Initiates Phase I Trial For ALV003

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Nutrition / Diet;  Clinical Trials / Drug Trials
Article Date: 15 Feb 2008 - 13:00 PDT

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Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, announced that the first study subject was dosed in a Phase 1 clinical trial of its lead clinical candidate ALV003 which is in development for the treatment of patients with celiac disease. ALV003 is an orally administered combination of two proteases engineered to detoxify gluten.

Approximately 36 subjects are planned for enrollment in the Phase 1, single-blind, placebo controlled, dose-escalation clinical trial to be conducted in the United States. Both healthy human volunteers and subjects with celiac disease are expected to be dosed in this trial.

"We are very excited to begin our clinical program evaluating ALV003 for the treatment of celiac disease," said Dr. Abhay Joshi, President and Chief Executive Officer of Alvine.

The October 25, 2007 issue of the New England Journal of Medicine discusses gluten detoxification as an approach to treating celiac disease. Authors Peter H.R. Green, M.D. and Christophe Cellier, M.D., Ph.D. state in the article: "There is considerable interest in the development of nondietary therapies that might either replace or supplement the rigorous gluten-free diet. Currently, the most attractive alternative involves the use of recombinant enzymes that digest the toxic gliadin fractions in the stomach or the upper small intestine."

About ALV003

ALV003 is an orally administered combination of two proteases engineered to digest gluten. It targets 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). The proposed mechanism of action of ALV003 is to digest gluten into non-immunotoxic fragments.

About Celiac Disease

Celiac disease is the most common hereditary autoimmune disease with prevalence as high as 1% in the U.S. and E.U. 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 food additives 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, other autoimmune diseases and malignancies. There are currently no approved pharmaceutical therapies for celiac disease. The only available treatment for individuals diagnosed with celiac disease is a life-long adherence to a strict gluten-free diet which is difficult to follow. There is a high unmet medical need for celiac disease therapies.

About Alvine

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 a combination protease engineered to digest gluten. It is being developed to treat patients with celiac disease.

Alvine Pharmaceuticals, Inc.