clinical trialAlbireo Limited, a clinical-stage biopharmaceutical company developing novel bile acid modulators to treat rare paediatric liver diseases, NASH and gastrointestinal (GI) disorders, has announced the initiation of a Phase III clinical trial in Japan of elobixibat, its product candidate for the treatment of chronic constipation, by Ajinomoto Pharmaceuticals Co., Ltd.

Ajinomoto Pharmaceuticals is the exclusive licensee of GI rights to elobixibat in Japan and other select markets in Asia. The Phase III trial, together with a planned clinical trial to evaluate the long-term safety of elobixibat in chronic constipation, represents the Phase III registration programme in Japan for elobixibat as a treatment for chronic constipation.

The Phase III clinical trial is a multicentre, double-blind, placebo-controlled study designed to enrol approximately 120 patients with chronic constipation. The trial design provides for patients to receive a once daily dose of elobixibat or a placebo for 2 weeks. The primary endpoint of the trial is the change in frequency of spontaneous bowel movements (SBMs) compared with baseline.

Previously, Ajinomoto completed a multicentre, double-blind, placebo-controlled Phase IIb clinical trial of elobixibat as a treatment for chronic constipation in Japan. Following a 2-week baseline period, patients in the trial were randomized to receive one of three doses of elobixibat, or a placebo, once daily for 2 weeks.

Of the randomized patients, 154 patients completed the trial. In the trial, both the mid and high elobixibat dose groups met the primary endpoint, change in number of weekly SBMs from baseline, with high statistical significance (p <0.001). All doses of elobixibat were generally well tolerated in the trial and no serious adverse events were reported.

Albireo has recently regained rights to elobixibat in the United States and otherwise outside of the territories licensed to Ajinomoto Pharmaceuticals. The company plans to meet with the US Food and Drug Administration to discuss the potential for an expedited development path to regulatory approval for elobixibat as a treatment for chronic idiopathic constipation (CIC) in the United States.