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Albireo Announces Positive Results From a Study With A3309 in Patients With Chronic Constipation
Date:4/29/2010

ory to OTC drugs," said Hans Graffner, Chief Medical Officer at Albireo. "The Albireo team looks forward to advancing the development of A3309, a first-in-class compound with a novel mode of action, and to create a new tool in the therapeutic armamentarium for these patients with limited treatment options."

A3309 is currently being evaluated in a large Phase IIb study in chronic constipation enrolling approximately 180 patients in the US and further investigation of A3309's enhancement of large bowel transit is being conducted at the Mayo Clinic. Also, given the mode of action, A3309 may be beneficial in patients with dyslipidemia and a study to evaluate A3309 in patients with high cholesterol levels is conducted in Sweden. Results of these clinical studies will be available late this year and plans are to move forward into Phase III in chronic constipation during 2011.

About the Results Presented at DDW

In the randomized, double-blind, placebo-controlled, prospective dose-escalating study, 30 patients were administered placebo or A3309 in a dose range of 0.1 mg - 10 mg for 14 days. In addition to evaluating safety and tolerability, bowel habits and gastrointestinal symptoms from patient diaries and radiographic assessments of transit were used to assess the efficacy of A3309.

There were no serious adverse events reported and no patient discontinued the trial. Adverse events were evenly distributed across the different dose levels and no difference was observed compared to placebo.

The mode of action - inhibition of bile acid re-absorption in the small bowel - was clearly demonstrated by biomarker analysis and colonic transit was improved in the higher dose groups as was the number of bowel movements. In addition, stool c
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SOURCE Albireo AB
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