Elobixibat meets endpoint in phase III trial for chronic constipation- Albireo

Albireo Limited announced positive top-line results from a pivotal Phase III clinical trial of its product candidate, elobixibat, in chronic constipation conducted in Japan. In the trial, elobixibat met the primary endpoint, change in the number of weekly spontaneous bowel movements (SBMs) from baseline to the first treatment week compared with placebo, with high statistical significance. The SBM endpoint is the endpoint required to support regulatory approval to treat chronic constipation in Japan.

The results of the trial also favored elobixibat with high statistical significance on all secondary efficacy endpoints assessed statistically, including assessments of change in frequency of complete SBMs, time to first SBM, severity of constipation and stool consistency. A complete SBM is an SBM without a self-reported sensation of incomplete evacuation. There were no serious adverse events reported in the trial. Consistent with prior clinical trials of elobixibat, the most common adverse events were abdominal pain (18.8%) and diarrhea (13.0%), all of which were characterized as mild or, in one case, moderate in severity.

Comments: Based on discussions with EA Pharma, Albireo expects that EA Pharma will file a new drug application for elobixibat in Japan in the first quarter of 2017 and make a milestone payment to Elobix AB, Albireo�s indirect wholly owned subsidiary, later in 2016 under the terms of the parties� license agreement.