Larazotide acetate is Fast Tracked by FDA
Baltimore, MD, - Alba’s Phase 2b clinical study (CLIN1001-012) is currently accepting patients in the U.S. and Canada.
Anyone interested in learning more about how they can participate in this clinical study or about CeD can visit the following Websites
“The CeD PRO questionnaire is an important tool for the continued development of larazotide acetate, our most advanced compound for the treatment of celiac disease,” said, Wendy Perrow, President and COO at Alba. “Understanding patients’ perspectives on specific disease related outcomes such as symptoms, and quality of life issues are critical to the development of new treatment options and are necessary parameters when evaluating them.”
The CeD PRO was developed in accordance with the U.S. Food and Drug Administration’s (FDA) SEALD guidelines, and is currently being validated in Alba’s Phase 2b multi-center trial evaluating the efficacy, safety and tolerability of larazotide acetate in patients with celiac disease. Larazotide acetate has the potential to become the first approved medicine to treat celiac disease and has been granted "Fast Track" designation from the FDA.
“Celiac Disease is a daily struggle for patients because excluding gluten entirely from the diet is virtually impossible,” said Anthony J. DiMarino, Jr., M.D., Chief, Division of Gastroenterology & Hepatology, Thomas Jefferson University Hospital in Philadelphia. “A potential drug therapy as an adjunct to diet could transform the treatment of Celiac Disease and help countless patients better manage their condition. Current research with Larazotide acetate has been promising. We will know more as the Phase II studies progress,” he added.
Five of the nation's leading health organizations supporting Celiac Disease awareness and education (Celiac Disease Foundation, Celiac Support Association, Gluten Intolerance Group of North America, National Foundation for Celiac Awareness and the American Celiac Disease Alliance) said: "We strongly support the efforts of Alba Therapeutics in its commitment to researching drug therapies for Celiac Disease. The more research that is undertaken, the better we will understand this disease and how best to help people effectively manage it."
About Larazotide Acetate
Larazotide acetate, Alba’s leading product candidate for CeD, is a novel agent that belongs to a new class of drug called tight junction regulators. Tight junctions, which are located in the bowel, should remain closed except to shed dead cells. However, in patients with CeD, the presence of gluten causes the tight junctions to remain open, thus starting an inflammatory cascade within the bowel that eventually destroys the intestinal villa. Early research suggests larazotide acetate may help keep the tight junctions closed when ingested prior to a meal, thus reducing the inflammatory process in response to gluten. More information about the mechanism of action of Larazotide acetate can be found in two newly published papers available in the May 2012 publication of PEPTIDES. Gopalakrishnan et al, Larazotide acetate regulates epithelial tight junctions in vitro and in vivo and Gopalakrishnan et al, Larazotide acetate promotes tight junction assembly in epithelial cells.
About Celiac Disease
Celiac disease affects 3 million people in the United States and approximately 15 million individuals worldwide. Celiac disease is an autoimmune disorder that is triggered by the ingestion of gluten, which is primarily found in bread, pasta, cookies, pizza crust and other foods containing wheat, barley or rye. People with celiac disease who are exposed to gluten experience an immune reaction in their small intestines, causing damage to the inner surface (villi) of the small intestine, and an inability to absorb certain nutrients. Signs and symptoms of celiac disease include intestinal pain, bloating, diarrhea and failure to thrive (infants and small children). Currently, there are no pharmacologic therapies available to treat this disease. The current management for celiac disease is to follow a gluten-free diet by eliminating foods that contain gluten. Unfortunately, the ability to maintain a strict gluten-free diet can be difficult, and up to 30 percent of patients respond poorly. For these patients, therapeutic modalities beyond dietary modification could be beneficial.