Albireo Unveils Plans for Phase 3 Clinical Program

Albireo Pharma, Inc. was out Thursday with key study design details for a planned phase 3 program of lead product candidate, A4250, in patients with progressive familial intrahepatic cholestasis (PFIC) determined following consultations with the U.S. Food and Drug Administration and European Medicines Agency. PFIC is a rare and life-threatening genetic liver disorder for which there are currently no approved drug therapies.

In parallel with the planned phase 3 program, Albireo says it is supporting an independent research study that is pooling and analyzing long-term PFIC patient data from a number of academic centers to support the clinical utility of the reduction of serum bile acids in the treatment of PFIC. Albireo plans to submit the findings from the study when available to both the FDA and EMA in support of its anticipated drug approval applications for A4250.