CALT - Calliditas randomizes first patient in phase 2b/3 study of setanaxib for liver disease

Calliditas Therapeutics (NASDAQ:CALT) said the first patient was randomized in a phase 2b/3 TRANSFORM study evaluating setanaxib in patients with primary biliary cholangitis (PBC). PBC is a disease in which the bile ducts in the liver are slowly destroyed. The 52-week global study will evaluate setanaxib 1200 mg/day and 1600 mg/day versus placebo on alkaline phosphatase reduction in patients with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid. The company said an interim analysis will be conducted once the 99th randomized patient has completed the Week 24 visit, which is expected H1 2023. The interim analysis outcome will determine which of the two doses will be used for the phase 3 part of the study. The trial will randomize ~318 patients at up to 150 investigational centers, and expects to report top line data in H2 2024/H1 2025. Calliditas had received the FDA's fast track designation for

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Calliditas randomizes first patient in phase 2b/3 study of setanaxib for liver disease