Alba Therapeutics Corporation today announced that it was granted a certificate of registration for copyright of the first and only Patient Reported Outcome (PRO) questionnaire for patients with Celiac Disease (CeD). The CeD PRO questionnaire will be used as part of Alba’s clinical trial program evaluating its investigational compound larazotide acetate, in patients with celiac disease. 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 PROwas 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 acetatehas 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 Sprue 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.