Albireo Pharma (ALBO) reports topline results from PEDFIC 1 Phase 3 Trial of Odevixibat. Odevixibat is a potent and selective inhibitor of the ileal bile acid transporter (IBAT), sometimes also referred to as the apical sodium dependent bile acid transporter (ASBT), that has minimal systemic exposure at therapeutic doses and acts locally in the gut.
In an open label Phase 2 study in children with cholestatic liver disease and pruritus, odevixibat showed reductions in serum bile acids and pruritus in most patients and exhibited a favorable overall tolerability profile.
The company is developing odevixibat initially to treat patients with PFIC, a rare genetic liver disease, and plan to consider additional development in other pediatric cholestatic liver diseases and disorders in the future. Our Phase 3 program in PFIC includes a single randomized, double-blind, placebo-controlled, multicenter clinical trial and an open-label long-term extension study. The double-blind trial, called PEDFIC1, is now underway and is designed to enroll approximately 60 patients with PFIC (subtypes 1 or 2), ages 6 months to 18 years, at sites in the United States, Canada, Europe, the Middle East and Australia.
How does Albireo Pharma (ALBO)’s Odevixibat work?
We are developing odevixibat initially to treat patients with PFIC, a rare genetic liver disease, and plan to consider additional development in other pediatric cholestatic liver diseases and disorders in the future. Our Phase 3 program in PFIC includes a single randomized, double-blind, placebo-controlled, multicenter clinical trial and an open-label long-term extension study.
The double-blind trial, called PEDFIC1, is now underway and is designed to enroll approximately 60 patients with PFIC (subtypes 1 or 2), ages 6 months to 18 years, at sites in the United States, Canada, Europe, the Middle East and Australia.
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