Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, joins the PFIC Advocacy and Resource Network (PFIC
Network) in recognition of PFIC Awareness Day 2020, a global effort
to support patients and families affected by progressive familial
intrahepatic cholestasis (PFIC). PFIC is a rare genetic disorder
that causes progressive, life-threatening liver disease
characterized by an intense form of itching called pruritus,
jaundice and difficulties gaining weight and maintaining proper
nourishment.
“PFIC Awareness Day is one of the many efforts PFIC Network is
undertaking to lift up the research, educational and advocacy needs
for this devasting and life-threatening disease,” said Emily
Ventura, executive director and co-founder of the PFIC Network. “We
are grateful for the global community’s support of people with PFIC
and their families on PFIC Awareness Day and every day, and
appreciate the research commitment of companies like Albireo.”
Established in 2019, PFIC Awareness Day aims to highlight the
impact of this disease on patients and families, and to call for
new levels of support, including research, advocacy, education and
opportunities to connect and share information. This year, members
of the PFIC community from countries around the world will come
together virtually by using the hashtag #ItchingForACure on social
media. PFIC Network is also offering additional ways to support
families, including the PFIC Network Lemonade Stand Fundraiser and
#ItchingForACure campaign apparel for purchase at www.pfic.org.
“Patients and families are our north star aligned to the mission
of providing hope to families by continuing to advance research for
a new drug treatment option for PFIC,” said Ron Cooper, President
and Chief Executive Officer of Albireo. “PFIC Awareness Day is an
opportunity for us to shine a light on patient voices, salute their
strength and perseverance, and show that we’re in this fight
together.”
To recognize PFIC Awareness Day, Albireo is supporting
#ItchingForACure with a social media campaign highlighting PFIC
families from around the world, including messages from families in
the United States, Canada, the United Kingdom and Australia. The
Company also continues to share patient perspectives about the
impact of PFIC through www.PFICVoices.com, an online platform for
information and support.
About PFIC PFIC is a rare genetic disorder that
causes progressive, life-threatening liver disease. People
diagnosed with PFIC have impaired bile flow, or cholestasis, caused
by genetic mutations. The resulting bile build-up in liver cells
causes liver disease and symptoms. The most prominent and
problematic ongoing manifestation of the disease is pruritus, or
intense itching, which often results in a severely diminished
quality of life. PFIC is also characterized by jaundice, and poor
weight gain and growth. In many cases, PFIC leads to cirrhosis and
liver failure within the first 10 years of life, and nearly all
people with PFIC require treatment before age 30. There are no
drugs currently approved for PFIC, only surgical options, including
a procedure known as partial external biliary diversion (PEBD) and
liver transplantation. These options carry substantial risks.
Additional information on PFIC is available at PFICvoices.com.
About AlbireoAlbireo Pharma is a clinical-stage
biopharmaceutical company focused on the development of novel bile
acid modulators to treat orphan pediatric 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 and has the potential to become the
first approved drug treatment for patients with PFIC. Albireo
recently reported positive results from PEDFIC 1, a global Phase 3
clinical trial evaluating the efficacy and safety of odevixibat,
which was the first and largest study ever conducted in PFIC1 and
PFIC2. The Company intends to complete regulatory filings in the EU
and U.S. no later than early 2021, in anticipation of potential
regulatory approval, issuance of a rare pediatric disease priority
review voucher and launch in the second half of 2021. The Company
also plans to initiate a pivotal Phase 3 trial of odevixibat in
Alagille syndrome by the end of 2020, and continues enrolling
patients in the BOLD pivotal Phase 3 trial of odevixibat in biliary
atresia. 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, 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 planned pivotal trial for odevixibat in
Alagille syndrome; 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 planned
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, elobixibat, 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; the period for which Albireo’s cash
resources will be sufficient to fund its operating requirements
(runway); 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 planned 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, the double-blind Phase 3 trial or other
pivotal 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.com
Investor Contact:Hans Vitzthum, LifeSci
Advisors, LLC., 617-430-7578
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