Albireo Announces Elobixibat Data from Japan to be Presented at DDW 2017
April 27 2017 - 08:00AM
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, placebo-controlled
study |
Abstract
Number: |
|
|
172 |
Session: |
|
|
Constipation and Colorectal Disorders |
Session
Number: |
|
|
2445 |
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.
About Elobixibat 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.
About Albireo 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.
Forward-Looking StatementsThis 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.
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com
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