Albireo initiates late-stage study of Odevixibat in pediatric liver disease

By 14/07/2020June 4th, 2021No Comments

Albireo Pharma has enrolled first patient in global Phase 3 trial (BOLD) of odevixibat for biliary atresia, expanding the development of odevixibat to a second rare cholestatic liver disease indication.

Odevixibat selectively inhibits a protein called the ileal bile acid transporter (IBAT), which plays a key role in transporting bile from the liver to the colon.

200-subject trial’s primary efficacy endpoint is improvement in the proportion of patients who are alive and have not undergone a liver transplant after two years of treatment, compared to placebo.

Children in the treatment arm will receive odevixibat and escalate to 120 μg/kg orally once daily for 24 months.

In addition to the BOLD and PEDFIC 1 trials, Albireo is finalizing a third pivotal trial of odevixibat in Alagille syndrome and anticipates to initiate the trial by the end of 2020.