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Enanta Announces Positive Results of ARGON-1 Study of its lead FXR Agonist, EDP-305, for the Treatment of NASH
Primary endpoint, ALT reduction at week 12, was met in the 2.5mg dosing group Key secondary endpoint, reduction in liver fat content as measured by MRI-PDFF
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nPrimary endpoint, ALT reduction at week 12, was met in the 2.5mg dosing group\n\n\n\n\nKey secondary endpoint, reduction in liver fat content as measured by MRI-PDFF at week 12, was met in the 2.5mg dosing group\n\n\n\n\nConference call and webcast with slides to discuss the ARGON-1 data at 4:30 p.m. ET today\n\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced topline results from its ARGON-1 Phase 2a study of EDP-305 for the treatment of non-alcoholic steatohepatitis (NASH).\n\n\nThe ARGON-1 study was a 12-week, randomized, double-blind, placebo-controlled Phase 2a study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in a NASH population. The primary objectives of the study were to evaluate change in ALT levels at week 12 and to evaluate the safety and tolerability of EDP-305. Key secondary objectives included change in liver fat content by MRI-PDFF, change in lipids, and pharmacokinetics and pharmacodynamic parameters, including C4 and FGF19.\n\n\nThe study’s primary endpoint was achieved with a statistically significant ALT reduction of 28 U/L in the EDP-305 2.5mg arm versus 15 U/L in the placebo arm at week 12 (p=0.049).\n\n\nAs with our primary endpoint, there was a statistically significant reduction in liver fat content with EDP-305 at the 2.5mg dose as measured by MRI-PDFF (p","length":1829,"tagName":"div"}]