BOSTON, April 27, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today 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.
Elobixibat is a once-daily, orally available ileal bile acid transporter (IBAT) inhibitor that is believed to improve both secretion and motility in the large bowel. 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.
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 Co., Ltd.
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,
|Session:||Constipation and Colorectal Disorders|
|Date / Time:||Saturday, May 6, 4:00-4:12 p.m. CDT|
|Location:||S406b, McCormick Place in Chicago|
|Presenter:||Atsushi Nakajima, MD, PhD; Division of |
Hepatogastroenterology, Yokohama City University Graduate
School of Medicine, Japan
Digestive Disease Week® is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
Elobixibat is a first-in-class product candidate to treat chronic idiopathic constipation (or, in Japan, chronic constipation). Elobixibat is an inhibitor of the ileal bile acid transporter (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 important functions in the small intestine. Elobixibat has been evaluated to date in more than 1,000 healthy volunteers and chronic constipation patients worldwide. A new drug application has been submitted to the Japanese Ministry of Health, Labour and Welfare for elobixibat for the treatment of chronic constipation in Japan.
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and 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.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit http://www.albireopharma.com.
This press release includes “forward-looking statements.” Forward-looking statements include statements, other than statements of historical fact, regarding Albireo’s intentions, plans, beliefs, expectations or forecasts for the future, including regarding regulatory approval or marketing of elobixibat in Japan. Albireo uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to: the outcome of the ongoing long-term safety clinical trial of elobixibat in Japan; the discretion that EA Pharma has in the development and potential commercialization of elobixibat in Japan; and the timing and success of acceptance and approval of the new drug application submitted to the Japanese Ministry of Health, Labour and Welfare for elobixibat for the treatment of chronic constipation in Japan. These and other risks and uncertainties are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Source: Albireo Pharma, Inc.
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