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From FDANews:
http://fdanews.com/newsletter/article?issueId=11622&articleId=107082
"Celiac Trial Results Inconclusive
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."
My understanding is that this trial was intended to determine whether
the drug could prevent the autoimmune reaction in celiacs exposed to
gluten.
Joel
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Joel Elias
www.rochesterceliacs.org
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