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Clinical Trials

Date: 2017-04-17

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the Digestive Disease Week (DDW) 2017

Company: Albireo Pharma (USA - MA) Albireo (Sweden) EA Pharma (Japan)

Product: elobixibat

Action mechanism:

  • ileal bile acid transporter (IBAT) inhibitor. Elobixibat is a first-in-class compound with a novel physiological mechanism of action. It acts locally in the gut with minimal systemic exposure and modulates the enterohepatic circulation of bile acids by a partial inhibition of the Ileal Bile Acid Transporter (IBAT). This increases colonic fluid secretion and motility.
  • EA Pharma, a subsidiary of Eisai Co., Ltd. focused in the gastrointestinal disease space, is the exclusive licensee of elobixibat for the treatment of gastrointestinal disorders in Japan and other select countries in Asia .

Disease: chronic constipation

Therapeutic area: Gastrointestinal diseases - Digestive diseases

Country: Japan

Trial details:

Latest news:

  • • On April 27, 2017, Albireo Pharma, a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced that clinical data from a Phase 2 study of elobixibat in chronic constipation conducted by EA Pharma Co., Ltd. in Japan is scheduled to be presented at Digestive Disease Week (DDW) 2017. Subsequent to completion of the Phase 2 clinical trial being presented at DDW, EA Pharma conducted a Phase 3 trial of elobixibat in chronic constipation with positive results and submitted an application for regulatory approval in Japan . Subject to receipt of regulatory approval, EA Pharma plans to co-market elobixibat in Japan with Mochida Pharmaceutical. Details of the DDW presentation are as follows: Title: Determining a clinical optimal dose of elobixibat, a novel  IBAT inhibitor, in Japanese patients with chronic constipation: a multicenter, randomized, double-blind, placebo-controlled study. Atsushi Nakajima , MD, PhD; Division of  Hepatogastroenterology, Yokohama City University Graduate  School of Medicine, Japan

Is general: Yes