Albireo Announces the Initiation in Japan of a Phase 3 Clinical Trial of Elobixibat in Chronic Constipation by Ajinomoto Pharmaceuticals
(Thomson Reuters ONE) -
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.
About Elobixibat
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.
About Albireo
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
info(at)albireopharma.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Albireo Limited via GlobeNewswire
[HUG#1965694]
Datum: 10.11.2015 - 13:00 Uhr
Sprache: Deutsch
News-ID 433435
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contact information:
Town:
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