Alba Therapeutics Announces Phase II Trial For Zonulin Antagonist AT-1001

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 22 Sep 2006 - 0:00 PDT

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Alba Therapeutics Corp. today announced that it had dosed its first patient in a Phase II trial for the treatment of Celiac Disease (CD). In October of last year, the FDA granted "Fast Track" designation to AT-1001, an orally administered zonulin receptor antagonist for treatment of Celiac Disease.

The multi-center, double blind, placebo controlled dose ranging study will evaluate the safety, tolerability and efficacy of AT-1001 in 79 Celiac Disease subjects during gluten challenge. "The initiation of the Phase II CD study is an important milestone for Alba Therapeutics as we continue to build our clinical experience with this disease and advance our program towards additional therapeutic applications for our zonulin antagonists," stated Dr. Blake Paterson, CEO of Alba. "Our understanding of the zonulin pathway coupled with AT-1001's excellent safety profile and the positive Phase Ib proof of concept data lead us to believe that the Phase II study will yield high quality results. Moreover, because there is no effective treatment for CD, entry into Phase II studies is a tremendous step forward for those patients suffering from this disease and other autoimmune diseases.

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 Zonulin

Zonulin is an endogenous signaling protein that transiently and reversibly opens the tight junctions ("tj") between the cells of epithelial and endothelial tissues such as the intestinal mucosa, blood brain barrier and pulmonary epithelia. Discovered by Alba's co-founder, Dr. Alessio Fasano, zonulin appears to be involved in many disease states in which leakage occurs via paracellular transport across epithelial and endothelial tight junctions (tj), and thus may play an important potential role in the treatment of autoimmune and inflammatory diseases.

About Alba

Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland. Alba is dedicated to commercializing disease-modifying therapeutics and vaccine and drug delivery adjuvants based on the zonulin pathway. Alba's lead molecule, AT-1001, is targeted towards the treatment of Celiac Disease and Type 1 Diabetes.

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