Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today announced upcoming poster presentations at
the North American Society for Pediatric Gastroenterology,
Hepatology and Nutrition (NASPGHAN) 2020 Annual Meeting, being
held virtually November 1-7. The company’s presentations will
include studies on lead product candidate odevixibat, a highly
potent, once-daily, non-systemic ileal bile acid transport
inhibitor (IBATi) currently being developed for the treatment of
progressive familial intrahepatic cholestasis (PFIC), biliary
atresia and Alagille syndrome.
“Our leading approach to rare cholestatic liver disease research
has been underscored this year, therefore, we are very pleased to
present new data on odevixibat at NASPGHAN,” said Ron Cooper,
President and Chief Executive Officer of Albireo. “Poster
presentations will also include a trial design overview of our
global, gold standard approach with the BOLD clinical trial
evaluating odevixibat, which is the largest Phase 3 trial in
biliary atresia, as well as health economics and outcomes research
focused on the burden of disease in PFIC.”
The Albireo poster presentations will be included in Poster
Session III on Friday, November 6 from 11 a.m. to 1 p.m. EST:
- Abstract #649: The BOLD Study: A Randomized,
Placebo-Controlled Trial to Evaluate the Efficacy and Safety of
Odevixibat (A4250) in Infants with Biliary Atresia After Kasai
Portoenterostomy
- Abstract #638: Drug-drug Interaction Study to
Evaluate the Interaction of A4250 (Odevixibat) with Itraconazole, a
P-gp Inhibitor in Healthy Adult Subjects
- Abstract #157: The PICTURE Burden of Illness
Study: Quantifying the Socio-economic Burden of Progressive
Familial Intrahepatic Cholestasis (PFIC) in the U.S., UK, France
and Germany
The abstracts are available as a supplement to the November
issue of the Journal of Pediatric Gastroenterology and Nutrition
and can be viewed at
https://journals.lww.com/jpgn/Documents/NASPGHAN%202020.pdf.
About OdevixibatOdevixibat is an
investigational product candidate being developed to treat rare
pediatric cholestatic liver diseases, including progressive
familial intrahepatic cholestasis (PFIC), biliary atresia and
Alagille syndrome. A highly potent, once-daily, non-systemic ileal
bile acid transport inhibitor (IBATi), odevixibat acts locally in
the small intestine. Odevixibat does not require refrigeration
and can be taken as a capsule for older children, or opened and
sprinkled onto food, which are factors of key importance for
adherence in a pediatric patient population. Albireo conducted the
largest ever global Phase 3 trial in PFIC1 and PFIC2. The PEDFIC 1
trial evaluated odevixibat 40 µg/kg/day or 120 µg/kg/day or placebo
in 62 patients, ages 6 months to 15.9 years. Positive results from
the trial were announced on September 8, 2020: News Release –
Albireo Phase 3 Trial Meets Both Primary Endpoints for Odevixibat
in PFIC. Odevixibat is currently being evaluated in the ongoing
PEDFIC 2 open-label trial (NCT03659916) and the BOLD Phase 3 trial
in patients with biliary atresia (NCT04336722). A pivotal Phase 3
trial of odevixibat for Alagille syndrome is also anticipated by
the end of 2020.
Odevixibat has received fast track, rare pediatric disease and
orphan drug designations in the United States. In
addition, the FDA has granted orphan drug designation to
odevixibat for the treatment of Alagille syndrome, biliary atresia
and primary biliary cholangitis. The EMA has granted
odevixibat orphan designation, as well as access to the PRIority
MEdicines (PRIME) scheme for the treatment of PFIC. Its Pediatric
Committee has agreed to Albireo’s odevixibat Pediatric
Investigation Plan for PFIC. EMA has also granted orphan
designation to odevixibat for the treatment of Alagille syndrome,
biliary atresia and primary biliary cholangitis. Odevixibat has the
potential to become the first approved drug treatment for patients
with PFIC. The Company intends to complete regulatory filings in
the EU and U.S. for odevixibat in PFIC 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.
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 is in Phase 3 development in
progressive familial intrahepatic cholestasis (PFIC) and biliary
atresia, with a third Phase 3 trial being planned in Alagille
syndrome. The Company expects to complete IND-enabling studies for
a new preclinical candidate this year. 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, 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; 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, 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
Contacts: Colleen
Alabiso, 857-356-3905, colleen.alabiso@albireopharma.com Heather
Anderson, 6 Degrees, 919-827-5539, handerson@6degreespr.com
Investor Contact: Hans Vitzthum, LifeSci
Advisors, LLC., 857-272-6177
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