Press Release Details

Albireo to Showcase New Data at AASLD The Liver Meeting® 2021

October 15, 2021

– Seven abstracts accepted highlighting data in pediatric cholestatic and viral liver diseases –

– Phase 3 Bylvay™ (odevixibat) data presentations on long-term treatment benefits show evidence of improved liver health and function across PFIC types –

– Data presentations on A2342, the first oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor for development in viral and cholestatic liver diseases –

– Company to host post-AASLD call on November 16, 2021 at 10 a.m. EST

BOSTON, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced the presentation of data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2021, being held virtually November 12 – 15. Data will be presented in one oral presentation and six posters across studies in rare pediatric cholestatic liver disease and in adult liver disease. Highlights to include data from the Phase 3 PEDFIC 1 study and PEDFIC 2 long-term extension study of Albireo’s product, Bylvay (odevixibat), and data from studies of viral disease product candidate, A2342. Abstracts are now available on the AASLD website and in the October supplement of HEPATOLOGY.

Pediatric Liver Presentations

Oral: Relationships Between Changes in Autotaxin, Pruritus, and Serum Bile Acids After Odevixibat Treatment in Patients With Progressive Familial Intrahepatic Cholestasis: Data From a Pooled Analysis
Presenter: Dr. Emmanuel Gonzalès, Associate Professor of Pediatric Hepatology and Liver Transplantation, University Hospitals of Paris-Sud, Bicetre, France
Session: Pediatric Hepatology: Metabolic and Genetic Diseases
Date & Time: Saturday, November 13, 4:00 p.m. EST

Poster #1950: Effects on Serum Bile Acids, Pruritus, and Safety With Up to 72 Weeks of Odevixibat Treatment: Pooled Data From the PEDFIC 1 and PEDFIC 2 Studies in Children With Progressive Familial Intrahepatic Cholestasis
Session Title: Pediatric Hepatology: Pediatric Liver Disease - Basic Science; Biliary Atresia and Neonatal Cholestasis; Viral and Autoimmune Liver Disease; Metabolic and Genetic Diseases; Pediatric Liver Transplantation

Poster #1951: Efficacy and Safety Outcomes With Odevixibat in Children With Progressive Familial Intrahepatic Cholestasis Due to Deficiencies in Multidrug Resistance Protein 3 (PFIC Type 3) or Myosin 5B (PFIC Type 6)
Session Title: Pediatric Hepatology: Pediatric Liver Disease - Basic Science; Biliary Atresia and Neonatal Cholestasis; Viral and Autoimmune Liver Disease; Metabolic and Genetic Diseases; Pediatric Liver Transplantation

Poster #1969: Natural Variation of Serum Bile Acid Levels and Pruritus in Children With Progressive Familial Intrahepatic Cholestasis: Pretreatment Data From Patients In The Phase 3 PEDFIC 1 Study
Session Title: Pediatric Hepatology: Pediatric Liver Disease - Basic Science; Biliary Atresia and Neonatal Cholestasis; Viral and Autoimmune Liver Disease; Metabolic and Genetic Diseases; Pediatric Liver Transplantation

Poster #1957: Hepatic Parameters, Growth, and Sleep With Responders and Nonresponders to Odevixibat Treatment: Pooled Data From the PEDFIC 1 and PEDFIC 2 Studies in Children With Progressive Familial Intrahepatic Cholestasis
Session Title: Pediatric Hepatology: Pediatric Liver Disease - Basic Science; Biliary Atresia and Neonatal Cholestasis; Viral and Autoimmune Liver Disease; Metabolic and Genetic Diseases; Pediatric Liver Transplantation

Adult Liver Presentations

Poster #837: Preclinical Characterization of the Novel, Orally Bioavailable Hepatitis B Viral Entry Inhibitor A2342
Session Title: Hepatitis B: Therapeutics: New Agents

Poster #848: Species-dependent Differences in Response to Sodium Taurocholate Cotransporting Polypeptide Inhibition: Translational Relevance To Human
Session Title: Hepatitis B: Therapeutics: New Agents

Post-AASLD Conference Call

Albireo will host a post-AASLD conference call and live audio webcast on November 16 at 10:00am EST. Presenters will include Ron Cooper, President and Chief Executive Officer; Patrick Horn, M.D., Ph.D., Chief Medical Officer and Jan Mattsson, Ph.D., Chief Scientific Officer and Co-Founder. To access the live conference call by phone, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and provide the access code 13724001.The virtual event will also be accessible from the Albireo Media and Investors page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay in the Events & Presentations section of the Media & Investors page of Albireo’s website for two weeks following the event.

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). 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 for sale in Germany 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 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 Alagille syndrome, 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 Alagille syndrome.

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 and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company has also initiated a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead 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. 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: Albireo’s commercialization plans and expectations for commercializing Bylvay in the U.S. and Europe; expectations about Bylvay’s acceptance by healthcare practitioners to treat PFIC patients; 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 pivotal trial for Bylvay in biliary atresia (BOLD), and the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907; 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 Bylvay in PFIC, and the BOLD and ASSERT trials; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of Bylvay of the treatment of PFIC patients and its potential to improve the current standard of care; or the potential benefits of an orphan drug designation. 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: there are no guarantees that Bylvay will be commercially successful; we may encounter issues, delays or other challenges in launching or commercializing Bylvay; whether Bylvay receives adequate reimbursement from third-party payors; the degree to which Bylvay receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in Bylvay in the treatment of patients with PFIC once we have launched the product may be different than observed in clinical trials, and may vary among patients; other 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 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 Bylvay, including BOLD and ASSERT, and the Phase 1 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, 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.com
Lauren Sneider, 857-300-1737, lauren.sneider@albireopharma.com

Investor Contact:
Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578


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Source: Albireo Pharma, Inc.