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Albireo Announces Positive Results in Patients With Chronic Idiopathic Constipation From a Phase IIb trial of A3309
Date:10/12/2010

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Albireo expects to present detailed results of the trial A3309-002 at upcoming scientific conferences.

Trial results

A3309-002 was a multicenter, randomized, double-blind, placebo-controlled trial conducted in the US and included 190 patients with severe constipation treated for an eight-week period. The patients included into the study were mainly female (90%) and experienced severe constipation as judged by a low number of weekly CSBMs (0.4/week). The patients had severe straining and bloating problems.

Primary endpoint

Change from Baseline in SBM Frequency during the first week of treatment

A higher frequency of SBMs occurred in all three active dose groups with statistically significant increased levels for the 10 mg and the 15 mg groups (p=0.002 and p<0.001 respectively). The numerical magnitude of change was 4.0 and 5.4 SBMs/week respectively in the two highest dose groups.

Main secondary efficacy endpoints

Change in SBM and in CSBM over the eight week treatment period

A3309 treated patients demonstrated a significant increase in average weekly CSBMs from baseline (1.0 for placebo; 2.4, 2.5 and 4.1 for 5 mg, 10 mg and 15 mg respectively and with p values being 0.021, 0.017 and <0.001 respectively). The overall change for SBMs followed the same pattern.

Time to First CSBM and Response Within 24 Hours

A3309 has a fast onset; the percentage of patients having a CSBM within 24 hours of starting therapy was 20, 31 and 55% in the active groups ((p=0.027 and p<0.001 for the two highest dose levels) compared to 10 % in the placebo group.

Other important symptoms of chronic constipation such as bloating, straining and hard stools were also relieved in higher proportions in the active dose groups.

Safety

No Serious Adverse events related to the treatment were reported.

Terminology used:

Spontaneous Bowel Movement (SBM): An SBM is
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SOURCE Albireo AB
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