French biopharmaceutical company Ipsen (Euronext Paris:IPN) (ADR:IPSEY) disclosed on Friday that its Phase III BOLD trial evaluating Bylvay (odevixibat) versus placebo in patients with biliary atresia who had undergone Kasai hepatoportoenterostomy (HPE) did not meet its primary endpoint of improving native liver survival.

Topline data was consistent with the established safety profile of odevixibat in approved indications.

Biliary atresia is a rapidly progressive paediatric liver disease with no approved therapeutic options beyond surgery, including Kasai HPE or liver transplantation. The company said BOLD, the first global Phase III trial in biliary atresia, generated a comprehensive dataset that may support future research and understanding of disease biology.

Bylvay is a once-daily selective ileal bile acid transport inhibitor that reduces bile acid reabsorption in the intestine. The treatment is approved in the United States for cholestatic pruritus in Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS). In the European Union, Bylvay is approved for the treatment of PFIC, with orphan exclusivity granted, and is additionally marketed as Kayfanda for ALGS.