Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company
developing novel bile acid modulators, today announced the
presentation of data at the European Society for Paediatric
Gastroenterology, Hepatology and Nutrition (ESPGHAN), being held
June 22 – 25, 2022 in Copenhagen, Denmark. Data will be presented
in three oral sessions and one poster, sharing analyses of the
landmark Phase 3 PEDFIC 1 study and PEDFIC 2 long-term extension
study of Bylvay in children with progressive familial intrahepatic
cholestasis (PFIC). These studies represent the largest Phase 3
clinical trials ever completed in PFIC. The full list of Albireo
presentations is listed below with abstracts on the ESPGHAN website
here.
Oral Presentation: Efficacy and Safety Outcomes
in Patients with Progressive Familial Intrahepatic Cholestasis Who
Had an Odevixibat Dose Escalation: Pooled Results from the PEDFIC 1
and PEDFIC 2 StudiesPresenter: Dr. Tassos
Grammatikopoulos, Consultant in Paediatric Hepatology &
Honorary Clinical Senior Lecturer, Institute of Liver Studies,
King’s College London Session Title: Parallel
Session: Hepatology 1 – Around PFIC and
HyperbilirubinemiaDate & Time: Thursday, 23
June, 17:00 CEST
Oral Presentation: Analysis of Quality of Life,
Hepatic Biochemical Markers, and Sleep in Patients With Progressive
Familial Intrahepatic Cholestasis Who Had a Pruritus Response With
Odevixibat TreatmentPresenter: Dr. Girish
Gupte, Liver Unit and Small Bowel Transplantation, Birmingham
Women’s and Children’s NHS Foundation TrustSession
Title: Parallel Session: Hepatology 1 – Around PFIC and
HyperbilirubinemiaDate & Time: Thursday, 23
June, 17:10 CEST
Oral Presentation: Changes in Hepatic
Parameters, Growth, Sleep, and Biochemical Markers With Odevixibat
Treatment Across Patients With Various Types of Progressive
Familial Intrahepatic CholestasisPresenter: Dr.
Lorenzo D’Antiga, Department of Paediatric Hepatology,
Gastroenterology, and Transplantation, Azienda Ospedaliera Papa
Giovanni XXIIISession Title: Plenary Session:
HepatologyDate & Time: Friday, 24 June, 09:15
CEST
e-Poster Abstract #363: Total, Primary, and
Secondary Serum Bile Acid Concentrations in Patients With
Progressive Familial Intrahepatic Cholestasis With Serum Bile Acid
Response or Not With Odevixibat Treatment: Assessing the
Contribution of Ursodeoxycholic Acid ConcentrationLead
Author: Dr. Henkjan J. Verkade, Department of Paediatrics,
University of Groningen, Beatrix Children’s Hospital/University
Medical Centre GroningenDate & Time: Friday,
24 June, 14:00 CEST
Breakfast Symposium: Real-life experience of
treating PFIC with an IBAT inhibitorExpert panel:
Prof. Patrick McKiernan, Birmingham Children's Hospital, NHS
Foundation Trust, UK, Dr Christoph Leiskau, Hannover Medical
School, Germany, Dr Angelo Di Giorgio, Hospital Papa Giovanni
XXIII, Bergamo, ItalyDate & Time: Saturday, 25
June, 7:15-8:15 CEST
About Bylvay (odevixibat)
Bylvay is the first drug approved in the U.S. for the treatment
of pruritus in patients 3 months of age and older in all types of
progressive familial intrahepatic cholestasis (PFIC). Limitation of
Use: Bylvay may not be effective in PFIC type 2 patients with
ABCB11 variants resulting in non-functional or complete absence of
bile salt export pump protein (BSEP-3). The European Commission
(EC) and UK Medicines and Healthcare Products Regulatory Agency
(MHRA) have also granted marketing authorization of Bylvay for the
treatment of PFIC in patients aged 6 months or older. Bylvay is
available in Germany and the UK and will be available for sale in
other European countries following pricing and reimbursement
approval. A potent, once-daily, non-systemic ileal bile acid
transport inhibitor, Bylvay acts locally in the small intestine.
Bylvay can be taken as a capsule for patients that are able to
swallow capsules, or opened and sprinkled onto food, which is a
factor of key importance for adherence in a pediatric patient
population. The most common adverse reactions for Bylvay are
diarrhea, liver test abnormalities, vomiting, abdominal pain, and
fat-soluble vitamin deficiency. The medicine can only be obtained
with a prescription. For more information about using Bylvay, see
the package leaflet or contact your doctor or pharmacist. For full
prescribing information, visit www.bylvay.com.
In the U.S. and Europe, Bylvay has orphan exclusivity for its
approved PFIC indications, and orphan designations for the
treatment of ALGS, biliary atresia and primary biliary cholangitis.
Bylvay is being evaluated in the ongoing PEDFIC 2 open-label trial
in patients with PFIC, in the BOLD Phase 3 study for patients with
biliary atresia and the ASSERT Phase 3 study for ALGS.
Important Safety Information
- The most common adverse reactions for Bylvay are diarrhea,
liver test abnormalities, vomiting, abdominal pain, and fat-soluble
vitamin deficiency.
- Liver Test Abnormalities: Patients should obtain baseline liver
tests and monitor during treatment. Dose reduction or treatment
interruption may be required if abnormalities occur. For persistent
or recurrent liver test abnormalities, consider treatment
discontinuation.
- Diarrhea: Treat dehydration. Treatment interruption or
discontinuation may be required for persistent diarrhea.
- Fat-Soluble Vitamin (FSV) Deficiency: Patient should obtain
baseline vitamin levels and monitor during treatment. Supplement if
deficiency is observed. If FSV deficiency persists or worsens
despite FSV supplementation, discontinue treatment.
About Albireo
Albireo Pharma is a rare disease company focused on the
development of novel bile acid modulators to treat rare pediatric
and adult liver diseases. Albireo’s lead product, Bylvay, was
approved by the U.S. FDA as the first drug for the treatment of
pruritus in all types of progressive familial intrahepatic
cholestasis (PFIC), and it is also being developed to treat other
rare pediatric cholestatic liver diseases with Phase 3 trials in
Alagille syndrome (ALGS) and biliary atresia, as well as Open-label
Extension (OLE) studies for PFIC and ALGS. In Europe, Bylvay has
been approved for the treatment of PFIC with pricing listing in
Germany and guidance from the National Institute for Health and
Care Excellence (NICE) recommending Bylvay for use in the National
Health Service in England, Wales and Northern Ireland. The Company
has also completed a Phase 1 clinical trial for A3907 to advance
development in adult cholestatic liver disease, with IND-enabling
studies progressing with A2342 for viral and cholestatic liver
disease. Albireo was spun out from AstraZeneca in 2008 and is
headquartered in Boston, Massachusetts, with its key operating
subsidiary in Gothenburg, Sweden. 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:
Albireo’s commercialization plans; the plans for, or progress,
scope, cost, initiation, duration, enrollment, results or timing
for availability of results of, development of Bylvay, A3907, A2342
or any other Albireo product candidate or program; the PEDFIC 2
open-label trial in patients with PFIC; the pivotal trial for
Bylvay in biliary atresia (BOLD); the pivotal trial for Bylvay in
Alagille syndrome (ASSERT); the Phase 2 study for A3907 the
IND-enabling or clinical studies for A2342; the target
indication(s) for development or approval; 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 Bylvay in PFIC, the BOLD and ASSERT trials, the
Phase 2 study for A3907, and the IND-enabling and clinical studies
for A2342; potential regulatory approval and plans for potential
commercialization of Bylvay in additional countries; the potential
benefits or competitive position of Bylvay or any other Albireo
product candidate or program or the commercial opportunity in any
target indication; future price listings and reimbursement
approvals of Bylvay; the length of time for which Albireo’s cash
resources are expected to be sufficient; 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,” or the
negative of these terms or other 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:
results achieved in Bylvay in the treatment of patients with PFIC
may be different than observed in clinical trials, and may vary
among patients; potential 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 Bylvay to date,
including findings in indications other than PFIC, will be
predictive of results from other clinical trials of Bylvay; ; the
timing for initiation or completion of, or for availability of data
from, clinical trials of Bylvay, including BOLD and ASSERT and the
Phase 2 clinical trial of A3907, and the outcomes of such trials;
Albireo’s ability to obtain coverage, pricing or reimbursement for
approved products in the United States or Europe; delays or other
challenges in the recruitment of patients for, or the conduct of,
the Company’s clinical trials; and the Company’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.comLance Buckley,
917-439-2241, lbuckley@lippetaylor.com
Investor Contact:Hans Vitzthum, LifeSci
Advisors, LLC., 617-430-7578
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