Alvine Pharmaceuticals Doses First Patient In Phase 2B Trial For ALV003 In Celiac Disease
SAN CARLOS, Calif., October 29, 2013 – Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, today announced that the first randomized study patient was dosed in the CeliAction Study™, a phase 2b study of its lead clinical candidate, ALV003, which is in development for the treatment of patients with celiac disease. ALV003 is an orally administered mixture of two gluten-specific proteases shown in vitro to degrade gluten, the primary immunologic trigger for celiac disease.
The CeliAction Study™, a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging clinical study will evaluate the safety and efficacy of ALV003 at different dose levels administered over a twelve-week period in approximately 500 patients in the United States, Canada and Europe.
“The CeliAction Study™ is one of the largest and most comprehensive clinical trials ever conducted in patients with celiac disease maintained on a gluten-free diet,” said Daniel Adelman, M.D., Senior Vice President of Development and Chief Medical Officer of Alvine Pharmaceuticals. “The data from this study will provide important insights into the potential treatment of the disease and prepare us for moving into late-stage development trials.”
The study is currently enrolling diagnosed celiac disease patients who are symptomatic despite attempting to follow a gluten-free diet. The study will evaluate the safety and efficacy of ALV003 administered over a twelve-week period; patients must remain on a gluten-free diet during the study.
The primary efficacy endpoint for the study is the change in small intestinal mucosal morphology as measured by the change in villus height to crypt depth ratio (Vh:Cd) from baseline and week 12 assessments. Secondary endpoints are the changes in density in intestinal intraepithelial lymphocytes and celiac disease-specific symptoms during the study. Other outcomes to be evaluated include changes in celiac disease serologies and quality-of-life measures. Approximately 120 patients will be allowed to stay on study treatment for an additional 12 weeks to continue measuring efficacy and safety.
Alvine previously presented results of its phase 2a study of ALV003 at the 2012 Digestive Diseases Week (DDW) Meeting in San Diego, California demonstrating that ALV003, when given in the context of a gluten-free diet, could diminish gluten-induced intestinal mucosal injury in well-controlled celiac disease patients.
“The results of this clinical study will significantly further our understanding of celiac disease and we strongly encourage the community of celiac disease patients to volunteer to enroll in the trial,” said Dr. Peter H. R. Green, Professor of Clinical Medicine, Columbia University College of Physicians & Surgeons, Director, Celiac Disease Center at Columbia University.
Additional information about the trial and study sites can be found on clinicaltrials.gov.
ALV003 is an orally administered mixture of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP). ALV003 targets gluten and degrades it into small fragments, which, in vitro, diminishes its immunogenicity. In a phase 2a study, ALV003 was shown to attenuate gluten-induced intestinal mucosal injury in celiac disease patients undergoing a daily gluten challenge. ALV003 is being developed as a potential treatment for celiac disease patients in conjunction with a gluten-free diet and is currently in phase 2b clinical development.
Celiac disease is one of the most common autoimmune diseases, affecting approximately 6 million people in the U.S. and Europe. Celiac disease is an acquired autoimmune disorder that develops in genetically susceptible individuals after exposure to dietary gluten, the protein found in wheat, rye and barley that humans cannot fully digest. Celiac disease is a systemic illness that can affect many organ systems, causing chronic gastrointestinal symptoms, such as nausea, diarrhea, and constipation, and can potentially cause serious medical consequences, including malabsorption, osteoporosis, anemia, and malignancies. Currently there is no approved therapy for celiac disease and the only option for patients is to attempt to follow a strict, life-long gluten-free diet.
Alvine Pharmaceuticals, Inc. is a private, clinical-stage, specialty biopharmaceutical company located in San Carlos, CA, focused on the development of biologics targeting autoimmune and inflammatory diseases, including celiac disease. Alvine is focusing clinical development efforts on ALV003, an investigational drug in Phase 2 trials that could potentially be the first approved therapeutic treatment for patients with celiac disease. For additional information about the company, please visit alvinepharma.com.
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