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Wednesday, November 15, 2006

Alba Therapeutics Presents Data from Positive Phase Ib Clinical Trial at the XII International Celiac Disease Symposium

New York, November 10, 2006

Source - Alba Therapeutics

Data presented on November 11th at the XII International Celiac Disease Symposium in New York City show that when AT-1001, an investigational oral zonulin receptor antagonist being developed for treatment of Celiac Disease (CD), was assessed in a double blind, placebo controlled study of CD patients, the product induced a positive result on the trial's primary endpoint, intestinal permeability. The objective of the Phase Ib proof of concept study was to establish the safety, tolerability and effectiveness of single doses of oral AT-1001 in adult CD patients in remission that are challenged with a large dose of gluten. Key findings from this Phase Ib study include:

• Intestinal barrier function was maintained by AT-1001 despite a supramaximal stimulus with gluten. There was a significant increase in permeability in placebo recipients but not in AT-1001 recipients following the 2.5 gram gluten challenge, as determined by urinary Lactulose-to-Mannitol (L-to-M) ratio.
• AT-1001 was generally safe and well tolerated, and no serious adverse events were reported.
• AT-1001 plasma concentrations were unmeasureable (< 0.5 ng/ml), indicating little to no systemic absorption when administered orally.
• The biological effect of AT-1001 persisted beyond the drugs residence time, suggesting that AT-1001 modulates both persistent leak and immune activation.
• Symptoms of acute gluten toxicity were inhibited in the AT-1001 arm when compared to placebo.

"AT-1001's inhibitory effect is most likely related to its capacity to prevent zonulin binding to its receptor on the lining of the gut, reducing exposure to gliadin and immune activation" stated Blake Paterson, M.D., Alba's Co-founder and CEO. "We are excited by the demonstration of a systemic immunological benefit arising from a physiological event at a mucosal surface of the small bowel, and look forward to completion of our Phase II clinical trial to further assess AT-1001's impact in this debilitating disease."

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