Wednesday, April 5, 2017

Enanta Announces Presentations at The International Liver Congress™ 2017

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

WATERTOWN, Mass.--(BUSINESSWIRE)--
  • New data to be presented on Enanta’s FXR agonist EDP-305 for non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC)
  • New data to be presented on AbbVie’s investigational, pan-genotypic, ribavirin-free HCV regimen that combines two distinct antiviral agents, including glecaprevir, Enanta’s second protease inhibitor
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.

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