Albireo today announced positive top-line results from a Phase IIb study in chronic idiopathic constipation (CIC) assessing efficacy and safety of three different dose levels (5, 10 and 15 mg orally once a day) of the investigational drug A3309 during an eight week trial. Analyses of the data show clinically meaningful and statistically significant improvement for patients treated with A3309 compared to placebo-treated patients. A3309 is a first-in-class IBAT inhibitor with minimal systemic exposure which is developed for the treatment of CIC and constipation-predominant irritable bowel syndrome (IBS-C).
The primary efficacy endpoint, change from baseline in spontaneous bowel movements (SBMs), showed a dose-dependent increase and highly significant results were obtained for the two highest dose levels. In addition, the secondary endpoints of effects on SBM and complete SBM (CSBM) frequencies were also dose dependent and statistically significant. Bloating and straining, important constipation symptoms, also decreased significantly during A3309 treatment. The effect of A3309 was rapid and a significantly higher proportion of the A3309-treated patients had a CSBM within 24 hours of the first administration. The beneficial effects were maintained over the eight week trial period.
"A3309 has a unique and novel mode of action which utilizes the body's physiologic processes to induce an increase in bowel movements. The results of this Phase IIb study show that A3309 has the potential to be an important therapeutic addition for patients with chronic constipation. I am sure that scientists and clinicians alike look forward to seeing further results with this exciting new compound" said William D. Chey, MD, Professor of Internal Medicine, University of Michigan, Ann Arbor.
"More than 30 million individuals suffer from CIC and IBS-C and the results of this Phase IIb trial further support the potential of A3309 to be an important treatment for these patients. The data in the trial presented today provide a solid base for moving forward into Phase III in 2011" said Hans Graffner, Chief Medical Officer of Albireo.
Albireo expects to present detailed results of the trial A3309-002 at upcoming scientific conferences.
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