GOTHENBURG, Sweden and LONDON, Nov. 10, 2015 (GLOBE NEWSWIRE) -- Albireo Limited, a clinical-stage biopharmaceutical company developing through its operating subsidiary novel bile acid modulators to treat rare pediatric liver diseases, NASH, and gastrointestinal (GI) disorders, announced today the initiation of a Phase 3 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 3 trial, together with a planned clinical trial to evaluate the long-term safety of elobixibat in chronic constipation, represents the Phase 3 registration program in Japan for elobixibat as a treatment for chronic constipation.
The Phase 3 clinical trial is a multicenter, double blind, placebo controlled study designed to enroll approximately 120 patients with chronic constipation. The trial design provides for patients to receive a once daily dose of elobixibat or placebo for two weeks. The primary endpoint of the trial is the change in frequency of spontaneous bowel movements (SBMs) compared to baseline.
Previously, Ajinomoto completed a multicenter, double blind, placebo controlled Phase 2b clinical trial of elobixibat as a treatment for chronic constipation in Japan. Following a two-week baseline period, patients in the trial were randomized to receive one of three doses of elobixibat, or placebo, once daily for two 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 U.S. Food and Drug Administration to discuss the potential for an expedited development path to regulatory approval for elobixibat as a treatment for CIC in the United States.
Elobixibat is a first-in-class product candidate in development for chronic idiopathic constipation. Elobixibat inhibits the ileal bile acid transporters (IBAT and also sometimes referred to as the apical sodium-dependent bile acid transporter) in the terminal ileum to increase secretion and motility in the large bowel without negatively affecting the small intestine. Elobixibat has been evaluated in over 900 healthy volunteers and chronic constipation patients to date worldwide.
Albireo Limited is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel locally acting bile acid modulators to treat diseases in which there is high unmet medical need, including rare pediatric liver diseases, nonalcoholic steatohepatitis (NASH), and debilitating gastrointestinal disorders. Albireo's clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008 and is backed by top-tier life science investors such as Phase IV Ventures, TPG Biotech, TVM Capital Life Science and Aberdeen Asset Management, as well as AstraZeneca.
Albireo Limited is incorporated and registered in England and Wales, and its wholly owned subsidiaries are located in Gothenburg, Sweden (including its operating subsidiary Albireo AB) and Boston, Massachusetts. For more information on Albireo, please visit www.albireopharma.com.
Albireo is a registered trademark of Albireo AB in key pharmaceutical markets in Europe.
CONTACT: Albireo Contact: Jan Mattsson Chief Operating Officer Tel: +46 31 741 14 80 email@example.com