Albireo expects Odevixibat PEDFIC 1 phase 3 topline data mid-2020
Albireo Pharmaprovided an update on the progress of the development of odevixibat for pediatric cholestatic liver diseases and elobixibat for NASH. The odevixibat PEDFIC program in progressive familial intrahepatic cholestasis, PFIC, consists of two clinical trials. PEDFIC 1 is a randomized, double-blind, placebo-controlled, global multicenter clinical trial designed to enroll approximately 60 patients with PFIC type 1 or type 2. PEDFIC 2 is an open-label extension study designed to assess long-term safety and durability of response in a cohort of patients rolled over from PEDFIC 1, and it includes a second cohort of PFIC patients who are not eligible for PEDFIC ."We are extremely encouraged with the recruiting efforts by the participating sites in our Phase 3 trial for odevixibat in PFIC, as we have now enrolled over half of the study. We also have a potentially sufficient number of patients currently in screening and prescreening to complete the study, and we expect to have topline data mid-2020. Approximately one third of the recruited patients to-date have been screen failures, which is higher than expected, but importantly, this provides greater homogeneity of the PFIC type 1 or type 2 patients who ultimately enroll in the trial, which preserves the integrity of the study," said Ron Cooper, President and Chief Executive Officer of Albireo. "In addition, we're excited to have screened the first patients in the Phase 2 study with once-daily elobixibat in NAFLD/NASH, as we believe elobixibat has the potential to find a significant place in the emerging NASH treatment landscape." PEDFIC 1 is a global study with 44 sites actively recruiting. The company expects topline data in mid-2020 and will provide a further update when the study has been fully enrolled.