Alba Therapeutics Announces the Presentation of Results of a Phase IIa Clinical Trial for Larazotide Acetate for the Treatment of Celiac Disease at the Digestive Disease Week ...( BALTIMORE May 21 /- Alba Therapeu...),Health

BALTIMORE, May 21 /PRNewswire/ -- Alba Therapeutics Corporation announced today that data from its Phase IIa clinical trial were presented in the Clinical Advances in Celiac Disease session at the Digestive Disease Week (DDW) meeting in San Diego, California. Results of the randomized, double- blind, placebo controlled study of larazotide acetate for the prevention of celiac disease reactivation by gluten challenge in celiac subjects in remission(1) were presented by Daniel Leffler, MD from Beth Israel Deaconess Medical Center at the DDW today.

Celiac disease affects approximately 1% of individuals in the United States and Europe or approximately 6.5 million individuals. The only accepted therapy for the disease is a strict gluten-free diet; however, the response to therapy is poor or incomplete in up to 30% of patients. Dietary non-adherence is the chief cause of persistent or recurrent symptoms(2). Over time, 30-50% of individuals are unable to maintain a strict gluten-free diet. Additionally, a gluten-free diet fails to induce clinical or histological improvement in 7-30% of celiac patients and such a lack of response should trigger a systematic evaluation(3). These facts suggest that there is a need for therapeutic modalities beyond dietary modification.

Alba's study, the first Phase IIa trial in celiac disease and the first to assess dosing requirements for larazotide acetate, was designed to evaluate the safety, tolerability and efficacy of multiple doses of larazotide acetate in celiac disease subjects during a 2 week gluten challenge. The randomized, double-blind, placebo-controlled clinical trial enrolled 86 patients 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 as demonstrated by a negative serology test of anti-transglutaminase (tTG). Patients were randomized into seven drug-treated and placebo groups and challenged three times a day w
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