Albireo Pharma is continuing to enroll participants for its phase 3 clinical trial called ASSERT to test the safety and efficacy of their nonsystemic ileal bile acid transport inhibitor odevixibat (Bylvay™) in patients with Alagille syndrome. The trial remains on track for topline results by the end of 2022.
“Bylvay launch uptake has been faster than anticipated and has significantly exceeded our internal expectations,” Ron Cooper, president and chief executive officer of Albireo said.
Alagille syndrome is characterized by intrahepatic bile duct paucity, which results in bile build-up inside the liver causing damage. The main symptoms of the disease include pruritus, jaundice, xanthomas, hepatomegaly, splenomegaly, dark urine, and light, loose, greasy, and odorous stools.
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By inhibiting ileal bile acid transport, odevixibat decreases the reabsorption of bile acids from the small intestine to the liver and could therefore help reduce bile acid accumulation in the liver. The treatment has been granted Orphan Drug Designation for the treatment of Alagille syndrome by the US Food and Drug Administration and the European Medicines Agency.
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ASSERT is a double-blind, randomized, placebo-controlled study that aims to enroll 63 participants with Alagille syndrome. Participants will receive an oral capsule once a day for 24 weeks. The primary outcome measure of the trial is the change from baseline to week 24 in scratching score.
Secondary outcome measures are serum bile acid levels and safety and tolerability. The trial is enrolling participants at 29 locations in the US, Canada, UK, Belgium, France, Germany, Italy, Netherlands, Poland Israel, and Malaysia. The estimated completion date of the study is July 2022.
Albireo is also testing the treatment in patients with pediatric cholestatic liver disease in a phase 3 clinical trial called BOLD, which already enrolled more than half its participants and also remains on track for topline results in 2024.
References
Albireo increases 2021 Bylvay™ (odevixibat) sales guidance. News release. Albireo; January 5, 2022.
Efficacy and safety of odevixibat in patients with Alagille syndrome (ASSERT). US National Library of Medicine. Updated December 30, 2021. Accessed January 12, 2021.
