Pediatric Liver Presentations
Oral Presentation: Rapid and Durable Effect of Odevixibat on Clinical and Biochemical Parameters of Cholestasis in Children With Progressive Familial Intrahepatic Cholestasis
Presenter: Dr.
Session: Rare liver disease (including paediatric and genetic)
Date & Time:
Poster PO-1811: Odevixibat Effects on Cholestasis-Related Parameters: Analysis of Pooled Data From the PEDFIC 1 and PEDFIC 2 Studies in Children With Progressive Familial Intrahepatic Cholestasis
Presenter: Dr.
Session: Rare liver diseases (including paediatric and genetic) ePoster Session
Date & Time:
Poster PO-1833: Odevixibat Therapy Improves Clinically Meaningful Endpoints in Children With Progressive Familial Intrahepatic Cholestasis: Data From the PEDFIC 1 and PEDFIC 2 Trials
Presenter: Lorenzo D'Antiga, M.D., Director of
Session: Rare liver diseases (including paediatric and genetic)
Date & Time:
Poster PO-1665: Substantial Clinical Benefits With Odevixibat Treatment Across Progressive Familial Intrahepatic Cholestasis Genetic Deficiencies: Subgroup Analysis of Serum Bile Acids, Pruritus, and Safety Using Pooled Data From the PEDFIC 1 and 2 Studies
Presenter:
Session: Rare liver diseases (including paediatric and genetic)
Date & Time:
Poster PO-1641: Long-term Treatment With Odevixibat Improves Multiple Sleep Parameters in Patients With Progressive Familial Intrahepatic Cholestasis: A Pooled Responder Analysis From the Phase 3 PEDFIC Studies
Presenter: Dr.
Session: Rare liver diseases (including paediatric and genetic)
Date & Time:
Poster PO-1843: Pretreatment Serum Bile Acid Parameters and Predictability of Response to Odevixibat, an Ileal Bile Acid Transporter Inhibitor, in Children With Progressive Familial Intrahepatic Cholestasis
Presenter: Henkjan Verkade, M.D., Ph.D., Professor of Pediatrics at the
Session: Rare liver diseases (including paediatric and genetic)
Date & Time:
Poster PO-1722: Epidemiology and burden of Progressive Familial Intrahepatic Cholestasis: Systematic Review
Presenter:
Session: Rare liver diseases (including paediatric and genetic)
Date & Time:
Adult Liver Presentations
Oral Presentation: A3907, a Novel, Orally Bioavailable Inhibitor of the Apical Sodium-Dependent Bile Acid Transporter, Improves Liver Injury in a Mouse Model of Cholestatic Liver Disease
Presenter:
Session: Targeting liver inflammation and fibrosis
Date & Time:
Poster PO-1849: A3907, a Novel Orally Available Inhibitor of the Apical Sodium-Dependent Bile Acid Transporter, Improves Key Clinical Markers of Non-Alcoholic Steatohepatitis in Obese Diet-Induced and Biopsy-Confirmed Mouse Models
Presenter:
Session: NAFLD: Experimental and pathophysiology
Date & Time:
All posters will be available to ILC participants on
About Bylvay (odevixibat)
Bylvay is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and ALGS. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay acts locally in the small intestine. Bylvay 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.
The FDA has granted Priority Review and set a PDUFA goal date of
The MAA and NDA filings are supported by results from PEDFIC 1 and PEDFIC 2 Phase 3 studies. PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial. In the PEDFIC 1 study, Bylvay met both primary endpoints and was well tolerated with very low incidence of diarrhea/frequent bowel movements (9.5% of Bylvay treated patients vs. 5.0% of placebo patients). ir.albireopharma.com/news-releases/news-release-details/albireo-phase-3-trial-meets-both-primary-endpoints-odevixibat. PEDFIC 2 is a long-term, open-label Phase 3 extension study. The Company also provides an Expanded Access Program (EAP) for eligible patients with PFIC in the
About Albireo
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 Bylvay or any other Albireo product candidate or program; expectations regarding the impact of the COVID-19 pandemic on our business and our ability to adapt our plans and activities as appropriate; the pivotal trial for Bylvay in biliary atresia (BOLD), and the pivotal trial for Bylvay 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 Bylvay in PFIC, BOLD, ASSERT and the Phase 1 clinical trial for A3907; the potential approval and commercialization of Bylvay and the timing for such potential approval and commercialization; the potential for Bylvay to become the first approved drug for PFIC patients; 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; 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,' 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: whether the NDA for Bylvay for the treatment of pruritus in patients with PFIC will be approved by the FDA and whether the MAA for Bylvay in PFIC will be approved by the EMA; whether the FDA or EMA will complete their respective reviews within the target timelines, including the
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