Alba Therapeutics Announces Phase IIb Clinical Trial For Oral AT-1001 For The Treatment Of Celiac Disease

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 20 Sep 2007 - 0:00 PDT

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Alba Therapeutics Corporation today announced that it has dosed its first patient in a six-week Phase IIb trial with oral AT-1001, an inhibitor of gastrointestinal barrier dysfunction, for the maintenance of remission in patients with Celiac Disease (CD). The multi-center, double-blind, placebo-controlled, dose ranging study will evaluate the efficacy, safety and tolerability of AT-1001 in CD subjects during a six-week gluten challenge, while also testing components of a Celiac Disease activity rating index, a new patient-reported outcomes instrument. "This is Alba's fifth human trial with AT-1001 and highlights our efforts to develop paradigms for the treatment of CD and for the assessment of activity in this neglected disease" stated Dr. Blake Paterson, CEO of Alba. "Since there is no effective treatment for CD and no validated means of measuring disease progression, the successful completion of this study will be a tremendous step forward for Celiac patients."

About Celiac Disease

Celiac Disease ("CD") is a T-cell mediated auto-immune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. According to the National Institutes of Health, CD affects approximately 3 million Americans. The only current treatment for CD is complete elimination of gluten from the diet, which results in remission for some patients.

About AT-1001

AT-1001 is an inhibitor of barrier dysfunction that has been shown to block intestinal permeability and the genesis of some autoimmune diseases, either as a result of reduction of antigen presentation to the body's immune system, or through some unknown inhibitory, direct effect on gastrointestinal associated lymphoid tissue. AT-1001 is orally formulated, has been granted "Fast Track" designation by the U.S. Food and Drug Administration for the treatment of Celiac Disease, and is also being evaluated for the treatment of Type 1 Diabetes and Crohn's Disease.

About Alba

Alba Therapeutics Corporation is a privately held, clinical-stage biopharmaceutical company based in Baltimore, Maryland. Alba is dedicated to development and commercialization of disease-modifying therapeutics to treat autoimmune and inflammatory disease, drug delivery agents and mucosal vaccine adjuvants by exploiting its technology to regulate the assembly and disassembly of tight junctions in cell barriers throughout the body.

Alba Therapeutics Corporation
http://www.albatherapeutics.com