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Enanta Pharmaceuticals Announces New Data Presentations at The Liver Meeting® 2016

Oct 03, 2016
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  • New pre-clinical data to be presented on Enanta’s FXR agonist EDP-305 for non-alcoholic steatohepatitis (NASH)
  • Preliminary Phase 1 data to be presented on Enanta’s novel host-targeted cyclophilin inhibitor EDP-494 for hepatitis C virus (HCV) patients.
  • New Phase 3 data to be presented on AbbVie’s investigational, pan-genotypic regimen for HCV consisting of glecaprevir (ABT-493), Enanta’s second protease inhibitor, in combination with pibrentasvir (ABT-530), AbbVie’s NS5A Inhibitor

WATERTOWN, Mass.--(BUSINESS WIRE)--Oct. 3, 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 that six poster presentations from Enanta’s wholly-owned development programs in non-alcoholic steatohepatitis (NASH) and hepatitis C virus (HCV) have been accepted for presentation 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 investigating Enanta’s Farnesoid X Receptor (FXR) EDP-305, currently in Phase 1 development, will be presented demonstrating its potency, selectivity and effects on fibrosis progression and lipid metabolism in pre-clinical models. A new FXR preclinical lead compound with enhanced potency, EP-024297, will also be characterized. Also being presented will be single- and multiple-ascending dose data in healthy volunteers, as well as preliminary viral kinetic data in genotype 1 and genotype 3 HCV patients treated with EDP-494, Enanta’s novel host-targeted cyclophilin inhibitor.

In addition, several presentations will report late-stage clinical data in genotypes 1-6 from AbbVie’s chronic HCV clinical development program of regimens containing glecaprevir, (ABT-493), Enanta’s second HCV protease inhibitor, in combination with pibrentasvir, (ABT-530), AbbVie’s NS5A inhibitor. There will also be several presentations reporting data from AbbVie’s ongoing clinical development program for its marketed HCV treatment regimens containing Enanta’s first protease inhibitor, paritaprevir. Enanta’s protease inhibitors were identified through its collaboration with AbbVie.

Enanta and AbbVie abstracts can now be viewed at the AASLD website at www.aasld.org.

Enanta Poster Presentations:

EDP-305 and EP-024297 FXR Agonists for Non-Alcoholic Steatohepatitis (NASH)
#650 - The Novel Farnesoid X Receptor (FXR) agonist, EDP-305, Reduces Fibrosis Progression in Bile Duct Ligated Rats

  • November 11, 8:00 am to 5:30 pm ET
  • Session: Imaging and Non-invasive Markers of Liver Disease
  • Author: C. Farrar, et al.

#1540 - EDP-305, A Novel and Selective Farnesoid X Receptor Agonist, Exhibits High Potency and Efficacy In Vitro and In Vivo

  • November 13, 8:00 am to 5:30 pm ET
  • Session: Steatohepatitis: Experimental I
  • Author: Y. Li, et al.

#1568 - EDP-305, A Novel and Highly Potent Farnesoid X Receptor Agonist, Exerts Favorable Effects on Lipid Metabolism In Vitro

  • November 13, 8:00 am to 5:30 pm ET
  • Session: Steatohepatitis: Experimental II
  • Author: Y. Li, et al.

#1569 - EP-024297, A Novel and Selective Farnesoid X Receptor Agonist, Exhibits High Potency and Efficacy In Vitro and In Vivo

  • November 13, 8:00 am to 5:30 pm ET
  • Session: Steatohepatitis: Experimental II
  • Author: M. Chau, et al.

#1596 - EDP-305, A Novel and Potent Farnesoid X Receptor Agonist, Exhibits Favorable Anti-inflammatory and Anti-fibrotic Activity In Vitro

  • November 13, 8:00 am to 5:30 pm ET
  • Session: Steatohepatitis: Experimental II
  • Author: Y. Li, et al.

EDP-494, Cyclophilin Inhibitor for HCV
#1453 - Safety, Tolerability, Pharmacokinetics (PK) and Antiviral Activity of EDP-494, a Potent Pan-Genotypic Cyclophilin (Cyp) Inhibitor for Chronic Hepatitis C Infection (CHC), in Healthy Subjects (HS) and in CHC Genotype 1 and 3 Patients: Preliminary Results

• November 13, 8:00 am to 5:30 pm ET

  • Session: HCV Therapeutics: Preclinical and Early Development
  • Author: E. Gane, et al.

AbbVie Presentations Regarding glecaprevir (ABT-493) for HCV:
Oral Presentations:
#73 – ENDURANCE 2: Safety and Efficacy of ABT-493/ABT-530 in Hepatitis C Virus Genotype 2-infected Patients without Cirrhosis, a Randomized, Double-Blind, Placebo-Controlled Study

  • November 13, Parallel E (Session 6-13); Parallel 11: Hepatitis C: New and Existing Agents
  • Time: 3:00 to 4:30 pm ET
  • Author: K. Kowdley, et al.

#113 – SURVEYOR II, Part 3: Efficacy and Safety of ABT-493/ABT-530 in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis

  • November 13, Parallel F, (Sessions 14-20); Parallel 17: Hepatitis C: Phase 2/3 Trials
  • Time: 4:45 to 6:15 pm ET
  • Author: D. Wyles, et al.

#114 – ENDURANCE 4: Efficacy and Safety of ABT-493/ ABT-530 Treatment in Patients with Chronic HCV Genotype 4, 5, or 6 Infection

  • November 13, Parallel F (Sessions 14 – 20); Parallel 17: Hepatitis C: Phase 2/3 Trials
  • Time: 4:45 to 6:15 pm ET
  • Author: T. Asselah, et al.

#253 – ENDURANCE 1: Efficacy and Safety of 8- versus 12-week Treatment with ABT-493/ABT-530 in patients with Chronic HCV Genotype 1 Infection

  • November 15, Viral Hepatitis Plenary Session
  • Time: 9:30 to 11:00 am ET
  • Author: S. Zeuzem, et al.

Poster Presentations Regarding glecaprevir (ABT-493):
#849 – Analysis of HCV Variants in the MAGELLAN-1 Part 1 Study: ABT-493 and ABT-530 Combination Therapy of Genotype 1-Infected Patients Who Had Failed Prior Direct Acting Antiviral-Containing Regimens

  • November 12, Poster Session II
  • Time: 5:30 to 7:30 pm ET
  • Author: T. Ng, et al.

#854 – Drug-drug Interactions between Direct Acting Antivirals ABT-493 and ABT-530 with Angiotensin II Receptor Blockers (losartan or valsartan)

  • November 12, Poster Session II
  • Time: 5:30 to 7:30 pm ET
  • Author: M Kosloski, et al.

#855 – Hemodialysis Does Not Affect the Pharmacokinetics of ABT‐493 or ABT‐530

  • November 12, Poster Session II
  • Time: 5:30 to 7:30 pm ET
  • Author: M Kosloski, et al.

About Enanta
Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral infections and liver diseases. Enanta’s research and development efforts are currently focused on four disease targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).

Enanta has discovered novel protease inhibitors and NS5A inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). Enanta’s protease inhibitors, developed through its collaboration with AbbVie, include paritaprevir, which is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir (ABT-493), Enanta’s second protease inhibitor, which AbbVie is developing in Phase 3 studies in combination with pibrentasvir (ABT-530), AbbVie’s NS5A inhibitor. Enanta has also discovered a cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for HCV, which is now in a clinical proof-of-concept study in HCV patients, and EDP-305, an FXR agonist product candidate for NASH, currently in Phase 1 clinical development. Please visit www.enanta.com for more information on our programs and pipeline.

Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie’s investigational HCV treatment regimen containing glecaprevir (ABT-493) and the prospects for Enanta’s further development of EDP-494, EDP-305 other FXR agonists. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the efforts of AbbVie (our collaborator developing glecaprevir) to develop and obtain regulatory approval of its regimen containing glecaprevir and successfully commercialize it; the development risks of early stage discovery efforts in HCV and in new disease areas such as NASH; the development, regulatory and marketing efforts of others with respect to competitive treatment regimens for HCV or for NASH; regulatory and reimbursement actions affecting any glecaprevir-containing HCV regimen, any competitive regimen, or both; Enanta’s lack of clinical development experience; Enanta’s need to attract and retain senior management and key scientific personnel; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others;and other risk factors described or referred to in “Risk Factors” in Enanta’s most recent Form 10-K for the fiscal year ended September 30, 2015 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

Source: Enanta Pharmaceuticals, Inc.

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Enanta Pharmaceuticals, Inc.
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