Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare
liver disease company developing novel bile acid modulators, today
joins the Alagille community in commemorating the second annual
International Alagille Syndrome Awareness Day on January 24, 2021
in honor of Dr. Daniel Alagille's birthday. Alagille syndrome
(ALGS) is a rare genetic disorder that can affect the liver, heart
and other parts of the body. Albireo leaders reaffirm the Company’s
commitment to advancing life-changing research and join the
community in bringing greater awareness to patients and families
affected by this rare and devastating disorder.
“Connecting with families who manage Alagille syndrome and
hearing firsthand the burdens associated with the disease reaffirms
our mission at Albireo, which is to provide hope and improve
treatment options and outcomes for children and families with rare
cholestatic liver diseases,” said Ron Cooper, President and Chief
Executive Officer of Albireo. “Their feedback has been invaluable
in helping design our Phase 3 study in Alagille syndrome, called
ASSERT, which is currently enrolling eligible patients.”
Alagille syndrome Alliance (ALGSA) 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. To recognize
International Alagille Syndrome Awareness Day, the organization
will be hosting a 24-hour “Aware-A-Thon” with the objective of
connecting families in raising awareness of ALGS through sharing
stories via social media. For more information, visit
www.alagille.org, or find the ALGSA on social media under
@ALGSAlliance.
“The Alagille syndrome community is one of tremendous courage,
determination and camaraderie. Our support groups with families
spanning the globe are filled with people dealing with all phases
and aspects of the syndrome. They encourage, lift up, lean on,
educate and help one another in so many ways,” said Roberta Smith,
President of Alagille Syndrome Alliance. “In honor of our families,
International Alagille Syndrome Awareness Day is a day to elevate
the patient voice, with focus on disease awareness and highlighting
Alagille education resources for all stakeholders as well as new
families stepping into this complex rare disease diagnosis.”
About ALGSAlagille syndrome (ALGS) is a rare,
multisystem genetic disorder that can affect the liver, heart,
skeleton, eyes, central nervous system, kidneys and facial
features. Liver damage is caused by a paucity of bile ducts
preventing bile flow from the liver to the small intestine.
Approximately 95% of patients with ALGS present with chronic
cholestasis, usually within the first three months of life, and up
to 88% also present with severe, intractable pruritus. Currently,
there are no approved drug treatments.
About AlbireoAlbireo Pharma is a clinical-stage
biopharmaceutical company focused on the development of novel bile
acid modulators to treat rare pediatric and adult liver diseases,
and other adult liver diseases and disorders. Albireo’s lead
product candidate, odevixibat, is being developed to treat rare
pediatric cholestatic liver diseases. The company recently
completed U.S. and EU regulatory submissions for odevixibat in
patients with progressive familial intrahepatic cholestasis (PFIC),
and anticipates potential regulatory approvals, issuance of a rare
pediatric disease priority review voucher and launch in the second
half of 2021. Odevixibat is also currently being evaluated in the
ASSERT Phase 3 trial in ALGS, BOLD Phase 3 trial in patients with
biliary atresia and the ongoing PEDFIC 2 Phase 3 open-label trial
in patients with PFIC. The Company also completed IND-enabling
studies for new preclinical candidate A3907 and plans to advance
development in adult liver disease. Albireo was spun out from
AstraZeneca in 2008 and is headquartered in Boston,
Massachusetts, with its key operating subsidiary
in Gothenburg, Sweden. The Boston Business
Journal named Albireo one of the 2020 Best Places to Work
in Massachusetts for the second consecutive year. For more
information on Albireo: 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, initiation, duration,
enrollment, results or timing for availability of results of,
development of odevixibat or any other Albireo product candidate or
program, including regarding expectations regarding the impact of
COVID-19 on our business and our ability to adapt our approach as
appropriate; the Phase 3 clinical program for odevixibat in
patients with PFIC, the pivotal trial for odevixibat in biliary
atresia (BOLD), and the pivotal trial for odevixibat in Alagille
syndrome (ASSERT); the target indication(s) for development or
approval, the size, design, population, location, conduct, cost,
objective, enrollment, duration or endpoints of any clinical trial,
or the timing for initiation or completion of or availability or
reporting of results from any clinical trial, including the
long-term open-label extension study for odevixibat in PFIC, the
pivotal trial for odevixibat in biliary atresia, the pivotal trial
for odevixibat in Alagille syndrome; the potential approval and
commercialization of odevixibat; discussions with the FDA or EMA
regarding our programs; the potential benefits or competitive
position of odevixibat or any other Albireo product candidate or
program or the commercial opportunity in any target indication; the
potential effects of odevixibat of the treatment of PFIC patients
and its potential to improve the current standard of care; the
potential benefits of an orphan drug designation; the potential
issuance of a rare pediatric disease priority review voucher; or
Albireo’s plans, expectations or future operations, financial
position, revenues, costs or expenses. 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: negative impacts of the
COVID-19 pandemic, including on manufacturing, supply, conduct or
initiation of clinical trials, or other aspects of our business;
whether favorable findings from clinical trials of odevixibat to
date, including findings in indications other than PFIC, will be
predictive of results from 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 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 pivotal program in biliary atresia or the pivotal program in
Alagille syndrome, 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, company’s clinical trials; 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:Colleen Alabiso,
857-356-3905, colleen.alabiso@albireopharma.comLisa Rivero,
617-947-0899, lisa.rivero@syneoshealth.com
Investor Contact:Hans Vitzthum, LifeSci
Advisors, LLC., 617-430-7578
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