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news.Alba Therapeutics has enrolled and randomized its first patient in a 12-week Phase IIb trial with oral larazotide acetate, an inhibitor of intestinal barrier dysfunction, for the treatment of patients with active celiac disease.
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The global multi-center, randomized, double-blind, placebo-controlled study will evaluate the clinical and histological efficacy, safety and tolerability of larazotide acetate in 106 active celiac disease subjects adhering to a gluten-free diet, while also testing components of a celiac disease activity rating index, a new patient reported outcomes instrument.
Francisco Leon, head of clinical R&D at Alba, said: “By conducting this important pioneering clinical study we believe we can learn more about celiac disease and provide insights for physicians and celiac patients.”