Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, commemorates the first International Alagille Awareness
Day on January 24, 2020, acknowledging pediatric hepatologist and
researcher Dr. Daniel Alagille, who first characterized the
syndrome. Alagille syndrome (ALGS)
is a rare
genetic disorder associated with liver, heart, eye and skeletal
abnormalities without an approved pharmacological treatment.
“International Alagille Syndrome Awareness Day brings this
condition to the forefront and it is an occasion to acknowledge and
celebrate our ALGS families,” said Cher Bork, Executive Director of
Alagille Syndrome Alliance (ALGSA). “We are grateful to our
partners like Albireo Pharma, who have taken time to meet families
in our community, and who are committed to supporting our efforts
to increase understanding about this condition.”
ALGSA (www.alagille.org) is an international advocacy group
representing patients and families. The nonprofit facilitates
in-person and digital forums to increase community education and
awareness among families, healthcare providers, and scientists.
ALGSA also provides assistance programs to families in need and
sponsors grants to advance scientific research.
“We celebrate the Alagille community’s successes in raising
awareness. Each win is a step in the right direction towards what,
hopefully, will be a better quality of life for everyone affected
by rare cholestatic liver diseases,” said Ron Cooper,
President and Chief Executive Officer of Albireo. “Since our
inception in 2008, Albireo has been relentlessly focused on
developing treatments for serious cholestatic liver diseases.”
Albireo is committed to improving treatment options and outcomes
for people with rare cholestatic liver diseases. Albireo initiated
the first pivotal trial in the cholestatic liver disease
progressive familial intrahepatic cholestasis, and plans to advance
development of its investigational product, odevixibat, in other
rare cholestatic liver diseases, which could include Alagille
syndrome.
About Albireo Albireo Pharma is a
clinical-stage biopharmaceutical company focused on the development
of novel bile acid modulators to treat orphan pediatric liver
diseases, and other liver and gastrointestinal diseases and
disorders. Albireo’s lead product candidate, odevixibat, is being
developed to treat rare pediatric cholestatic liver diseases and is
in Phase 3 development in its initial target indication,
progressive familial intrahepatic cholestasis. Albireo’s clinical
pipeline also includes two Phase 2 product candidates. Albireo’s
elobixibat, approved in Japan for the treatment of
chronic constipation, is the first ileal bile acid transporter
(IBAT) inhibitor approved anywhere in the world.
Albireo was spun out from AstraZeneca in
2008. Albireo Pharma is based in Boston, Mass., and
its key operating subsidiary is in Gothenburg, Sweden.
The Boston Business Journal named Albireo one of the 2019
Best Places to Work in Massachusetts. For more information on
Albireo, please visit www.albireopharma.com.
Forward-Looking Statements This press release
includes “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include statements, other than statements of historical
fact, regarding, among other things: the plans for, or progress,
scope, cost, duration or results or timing for availability of
results of, development of odevixibat, including regarding the
Phase 3 clinical program for odevixibat in patients with PFIC; the
target indication(s) for development, the size, design, population,
location, conduct, objective, enrollment, duration or endpoints of
any clinical trial, or the timing for initiation or completion of
or reporting of results from any clinical trial, including the
double-blind Phase 3 PFIC trial for odevixibat; the potential
approval and commercialization of odevixibat; the potential
benefits or competitive position of odevixibat or the commercial
opportunity in any target indication. Albireo often 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, uncertainties and other factors, including, but
not limited to: whether favorable findings from clinical trials of
odevixibat to date, including findings in indications other than
PFIC, will be predictive of results from the trials comprising the
Phase 3 PFIC program or any other clinical trials of odevixibat;
whether either or both of the FDA and EMA will determine
that the primary endpoint for their respective evaluations and
treatment duration of the double-blind Phase 3 trial in patients
with PFIC are sufficient, even if the primary endpoint is met with
statistical significance, to support approval of odevixibat
in the United States or the European Union, to treat
PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise;
the outcome and interpretation by regulatory authorities of the
ongoing third-party study pooling and analyzing of long-term PFIC
patient data; the timing for initiation or completion of, or for
availability of data from, clinical trials of odevixibat, including
the trials comprising the Phase 3 PFIC program, and the outcomes of
such trials; Albireo’s ability to obtain coverage, pricing or
reimbursement for approved products in the United
States or European Union; delays or other challenges in
the recruitment of patients for, or the conduct of, the
double-blind Phase 3 trial; and Albireo’s critical accounting
policies. These and other risks and uncertainties that Albireo
faces are described in greater detail under the heading “Risk
Factors” in Albireo’s most recent Annual Report on Form 10-K or in
subsequent 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.
Media Contact: Bill Berry, Berry & Company
Public Relations, (212)
253-8881, bberry@berrypr.com
Source: Albireo Pharma, Inc.
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