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TMCNet:  Enanta Pharmaceuticals Announces Data Presentations at The International Liver Congress™ 2017

[April 05, 2017]

Enanta Pharmaceuticals Announces Data Presentations at The International Liver Congress™ 2017

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 several abstracts regarding Enanta's wholly-owned EDP-305 development program for NASH and PBC, as well as abstracts regarding AbbVie's investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) for the treatment of chronic hepatitis C virus (HCV) infection, have been accepted for presentation at The International Liver Congress™ (ILC) 2017, April 19-23, in Amsterdam.

Three poster presentations will demonstrate that EDP-305 is a potent Farnesoid X Receptor (FXR) agonist that has been shown to reduce fibrosis progression and improve non-alcoholic fatty liver disease (NAFLD) activity scores (NAS) in a variety of preclinical models.

In addition, several oral and poster presentations will report data from AbbVie's G/P clinical development program. G/P is an investigational, pan-genotypic, once-daily regimen that combines two distinct direct-acting-antiviral (DAA) agents, glecaprevir, Enanta's second protease inhibitor, and pibrentasvir, AbbVie's NS5A inhibitor.

The following abstracts regarding EDP-305 and G/P will be presented during the International Liver Congress:

Enanta Presentations: EDP-305 FXR Agonist:

Thursday, April 20

Poster Presentation, 08:00 - 18:00

  • Poster #THU-377: A Novel Farnesoid X Receptor (FXR) Agonist, EDP-305, Reduces Fibrosis Progression in Animal Models of Fibrosis (Presenter: Bryan C. Fuchs)

Friday, April 21

Poster Presentation, 08:00 - 18:00

  • Poster #FRI-363: EDP-305, a Novel and Highly Potent Farnesoid X Receptor (FXR) Agonist, Improves Liver Steatosis, Ballooning and Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) in a Diet-Induced Murine Model of Non-Alcoholic Steatohepatitis (NASH) (Presenter: Li Juan Jiang)

Saturday, April 22

Poster Presentation, 08:00 - 18:00

  • Poster #SAT-459: A Novel FXR Agonist EDP-305 Potently Suppresses Liver Injury and Fibrosis in Mouse Models of Biliary and Metabolic Liver Disease (Presenter: Yury Popov)

AbbVie Presentations: glecaprevir/pibrentasvir (G/P) for HCV:

Thursday, April 20

Oral Presentation, 15:15 - 15:30

  • Abstract GS-006: EXPEDITION-I: Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (Presenter: Xavier Forns)

Poster Presentations, 08:00 - 18:00

  • Poster #THU-263: Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: an Integrated Analysis (Presenter: Edward Gane)
  • Poster #THU-305: Resistance Selection Using Glecaprevir and Pibrentasvir in Replicons of Major Hepatitis C Virus Genotypes (Presenter: Teresa Ng)

Late Breaking Poster April 20-22, 08:00 - 18:00

  • Poster #LBP-522: Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Co-infected With Hepatitis C Virus and Human Immunodeficiency Virus-1: the EXPEDITION-2 Study (Presenter: Juergen Rockstroh)

Friday, April 21

Oral Presentation, 08:30 - 08:45

  • Abstract GS-007: ENDURANCE-3: Safety and Efficacy of Glecaprevir/Pibrentasvir Compared to Sofosbuvir Plus Daclatasvir in Treatment-Na�ve HCV Genotype 3-Infected Patients without Cirrhosis (Presenter: Graham R. Foster)

Poster Presentations 08:00 - 18:00

  • Poster #FRI-205: Pooled Resistance Analysis in HCV Genotype 1-6-infected Patients Treated with Glecaprevir/Pibrentasvir in Phase 2 and 3 Clinical Trials (Presenter: Preethi Krishnan)
  • Poster #FRI-238: Safety of Glecaprevir/Pibrentasvir in Adults with Chronic Genotype 1-6 Hepatitis C Virus Infection: An Integrated Analysis (Presenter: Jean-Francois Dufour)
  • Poster #FRI-262: CERTAIN-1: Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients with Chronic Genotype 1 Hepatitis C Virus Infection with and without Cirrhosis (Presenter: Kazuaki Chayama)
  • Poster #FRI-263: Efficacy and Safety of Glecaprevir/Pibrentasvir in Japanese Patients with Chronic Genotype 2 Hepatitis C Virus Infection with and without Cirrhosis (Presenter: Kazuaki Chayama)

Saturday, April 22

Oral Presentations

  • 08:45 - 09:00: PS-156: MAGELLAN-1, Part 2: Glecaprevir and Pibrentasvir for 12 or 16 weeks in Patients with Chronic Hepatitis C Virus Genotype 1 or 4 and Prior Direct-Acting Antiviral Treatment Failure (Presenter: Fred Poordad)
  • 16:30 - 16:45: LBO-03: MAGELLAN-2: safety and efficacy of Glecaprevir/Pibrentasvir in Liver or Renal Transplant Adults with Chronic Hepatitis C Genotype 1-6 Infection (Presenter: Nancy Reau)

Poster Presentations, 08:00 - 18:00

  • Poster #SAT-204: Resistance Analysis in the MAGELLAN-1 Study (Part 2): Glecaprevir/Pibrentasvir Therapy in HCV-infected Patients who had Failed Prior DAA Regimens Containing NS3/4A protease and/or NS5A Inhibitors (Presenter: Tami Pilot-Matias)
  • Poster #SAT-233: High SVR Rates with Eight and Twelve Weeks of Pan-Genotypic Glecaprevir/Pibrentasvir: Integrated Efficacy and Safety Analysis of Genotype 1-6 Patients without Cirrhosis (Presenter: Massimo Puoti)
  • Poster #SAT-273: Safety and Efficacy of Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus Infection Genotype 1 - 6 and Chronic Kidney Disease: an Integrated Analysis (Presenter: Stan Pol)

The full ILC 2017 scientific program can be found at http://ilc-congress.eu/.

About G/P

G/P is an investigational, pan-genotypic regimen that is being evaluated by AbbVie as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAAs), who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as patients with genotype 3 HCV, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.

G/P is an investigational, once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.

Additional information on AbbVie's clinical trials for G/P is available at www.clinicaltrials.gov.

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 the following disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B virus (HBV).

Enanta has discovered novel protease inhibitors for use against the hepatitis C virus (HCV). These protease inhibitors, developed through Enanta's collaboration with AbbVie, include paritaprevir, currently marketed in AbbVie's HCV regimens, and glecaprevir (ABT-493), Enanta's second protease inhibitor product, which AbbVie is developing as part of its investigational, pan-genotypic HCV regimen of glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U. and Japan. Royalties and any further milestone payments from this collaboration will provide funding for Enanta's earlier development programs, including its Phase 1 FXR agonist program for NASH/PBC, and its preclinical programs for HBV and RSV. Please visit www.enanta.com for more information on Enanta's programs and pipeline.

Forward Looking Statements Disclaimer

This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie's G/P regimen for HCV and the prospects for Enanta's further development of EDP-305. 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 obtain regulatory approvals of its glecaprevir/pibrentasvir (G/P) combination and commercialize it successfully; the regulatory and marketing efforts of others with respect to competitive treatment regimens for HCV; regulatory and reimbursement actions affecting G/P, any competitive regimen, or both; the development risks of early stage discovery efforts in HCV and in new disease areas such as NASH; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; the need to obtain and maintain patent protection for glecaprevir and Enanta's other 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, 2016 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.


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