Albireo Pharma, Inc. announced new data from the Phase 3 PEDFIC 1 study and PEDFIC 2 long-term extension study of Albireo?s product, Bylvay (odevixibat), and first data from preclinical studies of cholestatic and viral disease product candidate, A2342. The data demonstrate evidence of long-term treatment benefits of Bylvay based on improved liver health and function across progressive familial intrahepatic cholestasis (PFIC) types that reduce the disease burden in the treatment of pruritus in PFIC. In addition, the company will showcase the first data from A2342 showing potential of sodium-taurocholate co-transporting peptide (NTCP) inhibition in viral and cholestatic liver diseases. The data will be presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting? 2021, which is being held virtually November 12 ? 15. The Company will present data on Bylvay in one oral presentation and four posters. Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi) that is approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC and in Europe for the treatment of all types of PFIC in patients aged 6 months or older. 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, and PEDFIC 2 is a long-term, open-label Phase 3 extension study. The observed safety and tolerability profile of Bylvay was consistent across studies, treatment groups and doses, regardless of PFIC classification or BSEP subtype. No drug-related serious adverse events were reported in either PEDFIC 1 or PEDFIC 2. Treatment-related diarrhea/frequent bowel movements reported in 9.5% of Bylvay treated patients in PEDFIC 1 and 5% of placebo-treated patients. Individual abstracts present data for specific safety and tolerability. The Company will also present data from its preclinical studies of A2342, the first oral NTCP inhibitor in development for viral and cholestatic liver diseases. IND-enabling studies for A2342 are currently being completed. Data to be presented is from studies on the impact of A2342 in models of in vitro and in vivo hepatitis B virus (HBV) infection and in animal models demonstrating NTCP target engagement.