Enanta Pharmaceuticals Announces HCV Data Presentations at The International Liver Congress™ 2016

  • New data to be presented on EDP-494, Enanta’s pan-genotypic cyclophilin inhibitor for Hepatitis C virus
  • New data to be presented on AbbVie’s investigational, pan-genotypic regimen consisting of ABT-493, Enanta’s second protease inhibitor, in combination with ABT-530, AbbVie’s NS5A inhibitor

WATERTOWN, Mass.--()--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 regimens containing either ABT-493 or paritaprevir, Enanta’s protease inhibitors being developed through its collaboration with AbbVie, as well as an abstract regarding EDP-494, Enanta’s wholly-owned pan-genotypic cyclophilin inhibitor for HCV infection, have been accepted for presentation at The International Liver Congress™ (ILC) 2016, in Barcelona, Spain, April 13-17.

New data will be presented from AbbVie’s investigational, pan-genotypic, once-daily, ribavirin-free regimen of ABT-493 and ABT-530 in patients with any of genotypes 1 through 6 chronic HCV infection, including data on treatment durations of as short as eight weeks in treatment-naïve, non-cirrhotic patients with genotype 1 (GT1), genotype 2 (GT2) or genotype 3 (GT3) chronic HCV infection. Additionally, abstracts being presented include real world data for regimens containing paritaprevir in patients with genotype 1 or genotype 4 chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis (Child-Pugh A). Also being presented are in vitro data on EDP-494, Enanta’s alternative, host-targeted antiviral approach to HCV that targets the human host protein cyclophilin for hard to treat HCV resistance associated variants.

The following abstracts regarding ABT-493, paritaprevir, and EDP-494, will be presented during the International Liver Congress:

ABT-493-containing Abstracts:

  • High Efficacy of ABT-493 and ABT-530 in HCV Genotype 1 Infected Patients Who Have Failed Direct-Acting Antiviral-Containing Regimens: The MAGELLAN-I Study. Poordad, F et al. Oral Presentation, General Session 2 and Awards 1: Friday, April 15 10:00am–10:15am; CEST, #GS11.
  • Late-Breaking Abstract: 100% SVR4 with ABT-493 and ABT-530 With or Without Ribavirin in Treatment-Naïve HCV Genotype 3-Infected Patients with Cirrhosis. Oral Presentation, Late-breaker session: Saturday, April 16 at 16:00pm–16:15pm CEST; #LB01
  • High SVR Rates With the Combination of ABT-493 + ABT-530 for 8 Weeks in Non-Cirrhotic Patients With HCV Genotype 1 or 2 Infection; Poordad, F et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-157
  • High SVR Rates With ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients With HCV Genotype 3 Infection; Muir, A et al. Oral Presentation, Viral Hepatitis C 2 Session: Saturday, April 16 at 11:45am–12:00pm CEST; #PS098
  • High Efficacy and Favorable Safety of ABT-493 and ABT-530 Co-Administration for 12 Weeks in HCV Genotype 1-Infected Patients With Cirrhosis (SURVEYOR-I); Gane, E et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-135
  • 100% SVR4 and Favorable Safety of ABT-493 + ABT-530 Administered for 12 Weeks in Non-Cirrhotic Patients with Genotypes 4, 5, or 6 Infection (SURVEYOR-I); Gane, E et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-137
  • Safety of ABT-493 and ABT-530 Co-Administered in Patients with HCV Genotype 1 – 6 Infection: Results From the SURVEYOR-I and SURVEYOR-II Studies; Kwo, P et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-239
  • ENDURANCE-3: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With HCV Genotype 3 Infection; Foster, G et al. Poster Presentation, Clinical Trials in Progress: Thursday, April 14 at 08:00am–18:00pm CEST; #THU-482
  • Pharmacokinetics, Safety, and Tolerability of Next Generation Direct Acting Antivirals ABT-493 and ABT-530 in Subjects with Hepatic Impairment; Kosloski, M P. Poster Presentation, Viral Hepatitis: Hepatitis C – clinical (new compounds, resistance): Thursday, April 14 at 08:00am–18:00pm CEST; #THU-230
  • Pharmacokinetics, Safety, and Tolerability of Next Generation Direct Acting Antivirals ABT-493 and ABT-530 in Subjects With Hepatic Impairment; Kosloski, M P. Poster Presentation, Viral Hepatitis: Hepatitis C – clinical (new compounds, resistance): Thursday, April 14 at 08:00am–18:00pm CEST; #THU-231
  • Analysis of HCV Genotype 2 and 3 Variants in Patients Treated with Combination Therapy of Next Generation HCV Direct-Acting Antiviral Agents ABT-493 and ABT-530; Ng, T. Poster Presentation, Viral Hepatitis: Hepatitis C – clinical (new compounds, resistance): Thursday, April 14 at 08:00am–18:00pm CEST; #THU-240
  • ABT-493 and ABT-530 Combination Demonstrated Minimal Potential for CYP-Mediated Drug-Drug Interactions; Kosloski, M P. Poster Presentation, Viral Hepatitis: Hepatitis C – clinical (new compounds, resistance): Thursday, April 14 at 08:00am–18:00pm CEST; #THU-229

Real World Evidence Abstracts Evaluating Paritaprevir-containing regimens:

  • Real-World Safety and Effectiveness of Ombitasvir/Paritaprevir/r With Dasabuvir and/or Ribavirin in the German Hepatitis C Registry; Hinrichsen, H et al. Oral Presentation, General Session 2 and Awards 1: Friday, April 15 at 08:30am–08:45am CEST; #GS07
  • Real-World Data on the Use of Ribavirin with Ombitasvir/Paritaprevir/r With or Without Dasabuvir in HCV Genotype 1 or 4-Infected Patients From the German Hepatitis C Registry; Welzel, T M et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-276
  • Late-Breaking Abstract: Analysis of the Real-World Effectiveness of Direct Acting Antiviral Treatments for Hepatitis C in a Large Population. McCombs, JS et al. Late breaker posters: Thursday, April 14 at 08:00am–Saturday, April 16 at 18:00pm CEST; #LBP-510

Clinical Trial Data Abstracts for Paritaprevir-containing regimens:

  • Late-Breaking Abstract: Effect of Baseline Resistance-Associated Variants on SVR with the 3D Regimen With and Without RBV in GT1a and GT1b-infected Patients; Sarrazin, C et al. Late breaker posters: Thursday, April 14 at 08:00am–Saturday, April 16 at 18:00pm CEST; #LBP-503
  • Efficacy and Safety of Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir Without Ribavirin in Patients with HCV Genotype 1b With or Without Compensated Cirrhosis: Pooled Analysis Across 5 Clinical Trials; Welzel, T M et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-273
  • A Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir in Non-Cirrhotic Adult Asians With HCV Genotype 1b; Lou, Y et al. Poster Presentation, Clinical Trials in Progress: Thursday, April 14 at 08:00am–18:00pm CEST; #THU-489
  • High SVR Rates in Patients with Genotype 4 Chronic Hepatitis C Infection and Compensated Cirrhosis With Ombitasvir/Paritaprevir/Ritonavir Co-Administered With Ribavirin (AGATE-I); Asselah, T et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-278
  • Improvement in Markers of Liver Fibrosis and Function in HCV Genotype 4-infected Patients with Compensated Cirrhosis Receiving Ombitasvir/Paritaprevir/Ritonavir with Ribavirin (AGATE-I); Hassanein, T I et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-277
  • Ombitasvir/Paritaprevir/Ritonavir with Ribavirin Achieves High Sustained Virologic Response (SVR) Rates in Egyptian Adults With Chronic HCV Genotype 4 Infection (AGATE-II); Waked, I et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-166
  • Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir Treatment of Patients With HCV Genotype 1-Infection Who Failed a Prior Course of DAA Therapy: The QUARTZ-I Study; Poordad, F et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-156
  • Reductions in Lifetime Risks of Liver-Related Morbidity and Mortality Associated with Novel Direct-Acting Antiviral Regimens Recommended for Treating Genotype 4 Non-Cirrhotic Hepatitis C Patients in the United States; Saab, S et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-108
  • Efficacy and Safety of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without Ribavirin, in Adults Treated with the Regimen Approved in Australia, Canada, New Zealand, and Switzerland; Gane, E et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-136
  • Sustained Virologic Response Predicts Fibrosis Regression Measured by FibroTest in HCV-infected Patients; Forns, X et al. Poster Presentation, Viral hepatitis: Hepatitis C – clinical (therapy): Saturday, April 16 at 08:00am–18:00pm CEST; #SAT-283

EDP-494 Cyclophilin Inhibitor:

  • EDP-494 is a Potent Pan-Genotypic Cyclophilin Inhibitor for HCV Infection, Including DAA Resistance Associated Variants (RAVS), C. Owens, et al. Poster presentation, Hepatitis C – experimental therapy: Thursday, April 14 at 08:00–18:00 pm CEST, #THU-250

The full ILC 2016 scientific program can be found at http://ilc-congress.eu/.

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 is 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 developed 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 ABT-493, Enanta’s second protease inhibitor, which AbbVie is developing in phase 3 studies in combination with ABT-530, AbbVie’s NS5A inhibitor. Enanta has also discovered a cyclophilin inhibitor, EDP-494, a novel host-targeting antiviral mechanism for HCV, which is now in phase 1 clinical development, and EDP-305, an FXR agonist, which Enanta plans to advance into clinical development for NASH later in 2016. 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 EDP-494 and for AbbVie’s ABT-493-containing regimen under development for HCV. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our 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 that may affect actual results include the efforts of AbbVie (our collaborator on ABT-493) regarding clinical development of ABT-493-containing regimens; the risks for EDP-494 associated with early clinical development; the impact of competitive products on the regulatory requirements, use and sales of any AbbVie regimen or any regimen containing EDP-494; 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.

Contacts

Investor Contact:
Enanta Pharmaceuticals, Inc.
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media Contact:
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com

Contacts

Investor Contact:
Enanta Pharmaceuticals, Inc.
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media Contact:
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com