Enanta Announces New Data On FXR Agonist EDP-305 For Non-Alcoholic Steatohepatitis (NASH) At The Liver Meeting® 2016

Enanta 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 new preclinical data from Enanta's wholly-owned program in non-alcoholic steatohepatitis (NASH) at the Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place November 11-15, 2016 in Boston.

New data is being presented on Enanta's Farnesoid X Receptor (FXR) agonist EDP-305, demonstrating its potency, selectivity and effects on fibrosis progression and lipid metabolism in pre-clinical models. Characterization of a new FXR preclinical lead compound with enhanced potency, EP-024297, will also be presented.

Detailed data will be available during each poster session.

Poster Presentations: EDP-305 and EP-024297 FXR Agonists for Non-Alcoholic Steatohepatitis (NASH)

November 13, 8:00 am - 5:30 pm ET#650 - The Novel Farnesoid X Receptor (FXR) agonist, EDP-305, Reduces Fibrosis Progression in Bile Duct Ligated Rats (C. Farrar , et al.)
  • Data demonstrated that EDP-305 reduced liver fibrosis in CDAHFD and BDL rodent models of NASH.

#1540 (Poster of Distinction) - EDP-305, A Novel and Selective Farnesoid X Receptor Agonist, Exhibits High Potency and Efficacy In Vitro and In Vivo (Y. Li, et al.)
  • Data demonstrated that EDP-305, a highly specific FXR agonist with minimal activity against TGR5, has potent effects on FXR-dependent gene expression in vitro and in vivo.

#1568 - EDP-305, A Novel and Highly Potent Farnesoid X Receptor Agonist, Exerts Favorable Effects on Lipid Metabolism In Vitro (Y. Li, et al.)
  • Data demonstrated that EDP-305 may have the potential to increase LDL clearance via up-regulation of LDLr and may potentially reduce HDL degradation by down-regulating the expression of hepatic lipase.

#1596 - EDP-305, A Novel and Potent Farnesoid X Receptor Agonist, Exhibits Favorable Anti-inflammatory and Anti-fibrotic Activity In Vitro (Y. Li, et al.)
  • Data demonstrated that EDP-305 exhibits the ability to regulate key genes involved in inflammation and fibrosis.

November 11, 8:00 am - 5:30 pm ET#1569 - EP-024297, A Novel and Selective Farnesoid X Receptor Agonist, Exhibits High Potency and Efficacy In Vitro and In Vivo (M. Chau, et al.)
  • Data demonstrated that EP-024297 is a sub-nanomolar agonist of FXR, and can regulate FXR-dependent gene expression in vivo at dose levels as low as 0.1 mg/kg.

"The additional preclinical data sets being presented at The Liver Meeting further demonstrate that EDP-305 is a highly selective FXR agonist with potent activity in a variety of in vitro assays and in vivo NASH models and fibrosis models," commented Jay R. Luly, Ph.D. "Our aim is to develop superior compounds to treat this debilitating disease, and we look forward to data from our ongoing clinical development program."

EDP-305 is currently in Phase 1 clinical development. Enanta's double-blind, placebo-controlled Phase 1a/b study is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses (SAD) and multiple ascending doses (MAD) of EDP-305 in healthy adults, and in adults with presumptive non-alcoholic fatty liver disease (NAFLD) (obese, with or without pre-diabetes or type 2 diabetes mellitus). The study will enroll approximately 90 subjects and is designed to evaluate up to 5 dose cohorts, with EDP-305 administered orally, once daily.

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