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www.fdanews.com/articles/107082-celiac-trial-results-inconclusive

Celiac Trial Results Inconclusive

May 27, 2008

Alba Therapeutics wrapped up its Phase IIa clinical trial of larazotide acetate for the prevention of celiac disease reactivation in celiac subjects in remission with some positive lessons but not the endpoint it wanted.

The study evaluated the safety, tolerability and efficacy of multiple doses of larazotide acetate in 86 subjects who had a confirmed biopsy diagnosis for celiac disease and were in compliance with a gluten-free diet for at least six months prior to enrollment.

The company said that although the primary study outcome was not statistically significant, a great deal was learned about the potential effects of larazotide acetate and new information was gained about the best way to run a celiac disease clinical trial.