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An Integrated Safety Analysis of Phase 2 Studies of BMS-986036, a PEGylated Fibroblast Growth
Factor 21 Analogue for the Treatment of Non-Alcoholic Steatohepatitis
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Reported by Jules Levin
EASL 2018 April 11-15 Paris France
Dina Halegoua-DeMarzio,1 Edgar D. Charles,2 Brent Neuschwander-Tetri,3 Sudeep Kundu,2 Giridhar S. Tirucherai,2 Rose Christian2
1Thomas Jefferson University, Philadelphia, Pennsylvania, USA; 2Bristol-Myers Squibb, Princeton, New Jersey, USA; 3Saint Louis University, St. Louis, Missouri, USA
BMS is conducting the FALCON Phase 2b program, which includes: FALCON 1 (MB130-068)(NCT#03486899), a randomized, double-blind, placebo controlled study evaluating the safety and efficacy of BMS-986036 in adults with NASH and stage 3 liver fibrosis and FALCON 2 (MB130-069)(NCT03486912), a randomized, double-blind, placebo controlled study evaluating the safety and efficacy of BMS-986036 in adults with NASH and compensated cirrhosis. Both FALCON 1 and 2 will be conducted in the U.S. and Japan.
AASLD:
BMS-986036 (PEGylated FGF21) in Patients with Non-Alcoholic Steatohepatitis: A Phase 2 Study - (10/26/17)
Baseline Serum Pro-C3 Predicts Response to BMS-986036 (PEG-FGF21): A Secondary Analysis of a Multi-Center Clinical Trial in Non-Alcoholic Steatohepatitis (NASH) - (11/29/17)
Multi-Biomarker Validation of MRI-PDFF- and MRE-Derived Treatment Response with BMS-986036 (PEG-FGF21): A Secondary Analysis of a Multi-Center Clinical Trial in Non-Alcoholic Steatohepatitis (NASH) - (11/29/17)
EASL/2017: BMS-986036 (pegylated FGF21) in patients with non-alcoholic steatohepatitis: A phase 2 study - (04/24/17)
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