ALBO - Albireo launches late-stage trial of odevixibat in Alagille Syndrome

Albireo Pharma (ALBO) initiates global Phase 3 trial, ASSERT, to evaluate odevixibat in patients with Alagille syndrome, a rare inherited disorder affecting the liver and other organs caused by bile duct abnormalities.Odevixibat is a non-systemic ileal bile acid transport inhibitor (IBATi).The 45-subject ASSERT study is Albireo’s third global trial in rare cholestatic liver conditions, and is designed to evaluate the safety and efficacy of 120 µg/kg/day odevixibat for 24 weeks in relieving pruritus (itchy skin related to a decrease or arrest of bile flow). Secondary endpoints will measure serum bile acid levels and safety and tolerability.Recently, the company submitted marketing applications to the FDA and EMA seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis.

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Albireo launches late-stage trial of odevixibat in Alagille Syndrome