Press Release Details

WATERTOWN, Mass.--(BUSINESS WIRE)--Oct. 1, 2014-- Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA) a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that 25 abstracts reporting the results of hepatitis C virus (HCV) treatment regimens containing ABT-450, Enanta’s lead protease inhibitor, or ABT-493, Enanta’s next-generation protease inhibitor, have been accepted for presentation at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), being held November 7-11, 2014 in Boston, MA.

ABT-450 and ABT-493 are protease inhibitors identified within the ongoing Enanta-AbbVie collaboration.

Abstracts will be presented highlighting results from AbbVie’s investigational treatment regimen combining three direct-acting antivirals (ABT-450/ritonavir, ombitasvir (formerly ABT-267) and dasabuvir, formerly ABT-333) with or without ribavirin (RBV) in patients with genotype 1 (GT1) chronic HCV infection. These abstracts include a phase 2/3 study in patients co-infected with human immunodeficiency virus type-1 (HIV-1) (TURQUOISE-I) and a phase 2 study in liver transplant recipients without cirrhosis (CORAL-I).

Additionally, phase 2 data will be presented from investigational studies evaluating the combination of ABT-450/ritonavir and ombitasvir with or without RBV in genotype 4 (GT4) patients (PEARL-I). AbbVie will also be presenting data from its two next-generation HCV compounds, ABT-493 and ABT-530. Results from these studies support the ongoing phase 2b combination studies in patients with HCV.

Abstracts can now be viewed at the AASLD website at www.aasld.org. Poster and oral presentations reporting regimens containing ABT-450 and ABT-493 are listed below:

Oral Presentations:
November 9, 2014, 5:15 - 5:30 p.m. ET

• #81. TURQUOISE-II: Regimens of ABT-450/r/Ombitasvir and Dasabuvir With Ribavirin Achieve High SVR12 Rates in HCV Genotype 1-Infected Patients with Cirrhosis, Regardless of Baseline Characteristics
  M.W. Fried; X. Forns; N. Reau; H. Wedemeyer; M.L. Shiffman; A. Castro; D.J. Mutimer; S.S. Lee; R. Trinh; S.S. Lovell; L. Canizaro; M. Pedrosa; T. Berg

November 9, 2014, 5:45 - 6:00 p.m. ET

• #83. Integrated Efficacy Analysis of Four Phase 3 Studies in HCV Genotype 1a-Infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir With or Without Ribavirin
  G.T. Everson; G. Dusheiko; E. Coakley; S.D. Shafran; F. Zoulim; M. Diago; B. Freilich; R. Ravinuthala; S. Norris; J.J. Xiong; R. Trinh; T. Baykal; Y. Luo; M.S. Sulkowski

November 11, 2014, 9:15 - 9:30 a.m. ET

• #198. High Sustained Virologic Response Rates in Liver Transplant Recipients With Recurrent HCV Genotype 1 Infection Receiving ABT- 450/r/Ombitasvir+Dasabuvir Plus Ribavirin
  P.S. Mantry; P.Y. Kwo; E. Coakley; H.S. Te; H.E. Vargas; R.S. Brown; F.D. Gordon; J. Levitsky;
  N. Terrault; J.R. Burton; W. Xie; C. Setze; P. Badri; R.A. Vilchez; X. Forns

November 11, 2014, 12:15 - 12:30 p.m. ET

• #227. Epigenetic Analysis of the IFNλ3 Gene Identifies a Novel Marker for Response to Therapy in HCV-infected Subjects
  Jeffrey F. Waring; Emily Dumas; Eoin Coakley; Daniel E. Cohen; Kenneth B. Idler; Ujjwal Das; Thomas Podsadecki; Sandeep Dutta

November 11, 2014, 12:00 - 12:15 p.m. ET

• #238. The Pharmacokinetics and Safety of the Direct Acting Antiviral Regimen of ABT-450/r, Ombitasvir with/without Dasabuvir in Subjects with Mild, Moderate and Severe Renal Impairment Compared to Subjects with Normal Renal Function
  A. Khatri; S. Dutta; T.C. Marbury; R.A. Preston; L. Rodrigues-Jr; H. Wang; W. Awni; R. Menon

ABT-493-Related Poster Presentations:
November 11, 2014, 8:00 a.m. - 12:00 p.m. ET:

• #1946. A Next Generation HCV DAA Combination: Potent, Pangenotypic Inhibitors ABT-493 and ABT-530 with High Barriers to Resistance
  T. Ng; T. Pilot-Matias; L. Lu; T. Reisch; T. Dekhtyar; P. Krishnan; J. Beyer; R. Tripathi; R.B. Pithawalla; A. Asatryan; A.L. Campbell; J. Kort; C. Collins

• #1956. Potent Antiviral Activity of ABT-493 and ABT-530 With 3-Day Monotherapy in Patients With and Without Compensated Cirrhosis With Hepatitis C Virus (HCV) Genotype 1 Infection
  E. Lawitz; W.D. O'Riordan; B.L. Freilich; T.D. Box; J. Overcash; W. Liu; A.L. Campbell; C. Lin; A Asatryan; J. Kort

• #1986. Pharmacokinetics and Safety of Pan-Genotypic, Direct Acting Protease Inhibitor, ABT-493, and NS5A Inhibitor, ABT-530, Following 3 day Monotherapy in HCV Genotype-1 Infected Subjects with or without Compensated Cirrhosis
  Chih-Wei Lin; Wei Liu; Armen Asatryan; Andrew L. Campbell; Sandeep Dutta

ABT-450-Related Poster Presentations:
November 11, 2014, 8:00 a.m. - 12:00 p.m. ET:

• #1928. Interferon-Free Regimens of Ombitasvir and ABT-450/r With or Without Ribavirin in Patients With HCV Genotype 4 Infection: PEARL-I Study Results
  S. Pol; K. Reddy; T. Baykal; C. Hezode; T. Hassanein; P. Marcellin; M. Berenguer; K.M. Fleischer-Stepniewska; C. Hall; C. Collins; R.A. Vilchez

• #1931. SVR12 Rate of 98.6% in 992 HCV Genotype 1b-Infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir With or Without Ribavirin
  M. Colombo; O. Weiland; D.E. Cohen; J.J. DuFour; H. Reynaert; M. Diago; E. Villa; A. Streinu-Cercel; W. Xie; T. Baykal; J. Enejosa; E. Coakley; R. Trinh; T. Podsadecki

• #1933. PEARL-IV Trial: Subgroup Analysis of Genotype 1a-Infected Patients Treated With ABT-450/r/Ombitasvir With Dasabuvir With or Without Ribavirin
  D. Bernstein; Y. Luo; J.P. Lalezari; D.L. Wyles; W. King; N. Tsai; M.N. Davis; T.E. Sepe; J. Fessel; M. King; T. Podsadecki; C. Cooper

• #1934. SVR12 Rate of 95.7% in 209 HCV Genotype 1-Infected Null Responders Treated With ABT-450/r/Ombitasvir and Dasabuvir With or Without Ribavirin
  I.M. Jacobson; J.J. DuFour; J. Enejosa; R.J. de Knegt; P. Ferenci; H. Reynaert; A.M. Di Bisceglie; L. Larsen; T. Baykal; L. Rodrigues-Jr; T. Podsadecki; D.M. Jensen; F. Poordad

• #1936. Pooled analysis of resistance in patients treated with ombitasvir/ABT- 450/r and dasabuvir with or without ribavirin in Phase 2 and Phase 3 clinical trials
  P. Krishnan; R. Tripathi; G. Schnell; T. Reisch; J. Beyer; M. Irvin; W. Xie; L. Larsen; T. Podsadecki; T. Pilot-Matias; C. Collins

• #1938. ABT-450/r/Ombitasvir + Dasabuvir With or Without Ribavirin in HCV Genotype 1-infected Patients Receiving Stable Opioid Substitution Treatment: Pooled Analysis of Efficacy and Safety in Phase 2 and Phase 3 Trials
  M. Puoti; C. Cooper; M.S. Sulkowski; G.R. Foster; T. Berg; E. Villa; F. Rodriguez-Perez; V. Rustgi; D.L. Wyles; M. King; B.H. McGovern; H. Wedemeyer

• #1939. TURQUOISE-I: 94% SVR12 in HCV/HIV-1 Coinfected Patients Treated with ABT-450/r/Ombitasvir, Dasabuvir and Ribavirin
  D.L. Wyles; M.S. Sulkowski; J.J. Eron; R. Trinh; J. Lalezari; J. Slim; J.C. Gathe; C.C. Wang; R. Elion; F. Bredeek; R.O. Brennan; G. Blick; A. Khatri; K. Gibbons; Y. Hu; L. Fredrick; T. Pilot-Matias; B. Da Silva-Tillmann; B.H. McGovern; A.L. Campbell; T. Podsadecki

• #1950. Time to Viral Suppression is Not Related to Achievement of SVR12 in HCV GT1-infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir With or Without Ribavirin
  M.S. Sulkowski; M.W. Fried; R. Ozaras; V. Isakov; D.L. Wyles; P. Ferenci; J.J. Feld ; F. Calinas; M. Gschwantler; M. King; T. Baykal; E.J. Gane

• #1951. Safety of ABT-450/r/Ombitasvir + Dasabuvir With or Without Ribavirin in HCV Genotype 1-infected Patients: Results From Phase 2 and Phase 3 Trials
  M.W. Fried; A.M. Di Bisceglie; J.M. Vierling; E.J. Gane; F. Nevens; S.I. Strasser; O. Weiland; S. Rugina; S.S. Lovell; B. Da Silva-Tillmann; N. Shulman; N. Tsai; D.R. Nelson

• #1953. Adherence to Prescribed Doses of ABT-450/r/Ombitasvir, Dasabuvir, and Ribavirin in the Phase 3 PEARL-II, PEARL-III, and PEARL-IV Trials
  D. Bernstein; R.T. Marinho; D.E. Cohen; F. Bredeek; F. Schneider; G.P. Norkrans; M.G. Curescu; M. Bennett; M. Maevskaya; J. Fessel; W. Xie; Y. Luo; J. Enejosa

• #1954. Identification and treatment of multiple subtypes of HCV genotype 4 in the PEARL-I study with ombitasvir and ABT-450/r ± ribavirin
  G.Schnell; R. Tripathi; J. Beyer; T. Reisch; P. Krishnan; T. Baykal; C. Hall; R.A. Vilchez; T. Pilot-Matias; C. Collins

• #1957. Pharmacokinetics of Cyclosporine and Tacrolimus, Following Co-administration with the Direct Acting Antiviral Combination, ABT- 450/r, Ombitasvir and Dasabuvir, in Liver Transplant Patients with Genotype-1 HCV Infection
  P. Badri; A. Parikh; E. Coakley; B. Ding; W. Awni; S. Dutta; R. Menon

• #1961. Safety of ABT-450/r/Ombitasvir + Dasabuvir With or Without Ribavirin in HCV Genotype 1-infected Patients: Results From PEARL II, PEARL III, and PEARL IV
  J.P. Lalezari; R. Pruitt; Y. Luo; R.J. Aspinall; G.B. Gaeta; I. Olszok; W. King; S. Gurel; Y. Hu; J. Enejosa;
  D.E. Cohen; N. Shulman; V.A. Luketic

• #1962. TURQUOISE-II: Trends in Liver Fibrosis Testing, Hepatic Synthetic Function, and Platelet Counts at Baseline and 12 Weeks After Treatment With ABT-450/r/Ombitasvir and Dasabuvir With Ribavirin in HCV Genotype 1-Infected Patients with Cirrhosis
  M.L. Shiffman; K.V. Kowdley; S. Zeuzem; D.J. Mutimer; M. Bourlière; T. Berg; S.S. Lee;S.S. Lovell; L. Canizaro; R. Trinh; G. Neff; P.Y. Kwo

• #1968. Efficacy by Race or Geographic Region in HCV Genotype 1-infected Patients Treated with ABT-450/ritonavir/Ombitasvir and Dasabuvir With or Without Ribavirin
  J.M. Vierling; M. Puoti; D. Bernstein; N. Tsai; O. Weiland; M. Romero Gómez; F.A. Caruntu; J.J. DuFour; F. Calinas; L. Larsen; F. Tatsch; P. Andreone

• #1969. Safety of ABT-450/r/Ombitasvir + Dasabuvir With or Without Ribavirin in HCV Genotype 1-infected Patients ≥65 Years of Age: Results From Phase 2 and 3 Trials
  S.L. Flamm; E.J. Gane; J.J. DuFour; V. Rustgi; V.G. Bain; D.H. Crawford; P. Andreone; T. Hassanein; W.W. Mazur; S.S. Lovell; B. Da Silva-Tillmann; N. Shulman; M. Puoti; T.D. Box; I.M. Jacobson

• #1972. ABT-450/r/Ombitasvir + Dasabuvir With or Without Ribavirin in HCV Genotype 1-infected Patients with History of Depression or Bipolar Disorder: Pooled Analysis of Efficacy and Safety in Phase 3 Trials
  D.R. Nelson; K. Reddy; A.M. Di Bisceglie; P. Ferenci; D.H. Crawford; R.E. Stauber; A.A. Yakovlev; V. de Ledinghen; H. Hinrichsen; D. Bernstein; R.J. de Knegt; T. Hassanein; S. Norris; J.J. Xiong; B.H. McGovern; K. Agarwal

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 in the infectious disease field. Enanta is discovering, and in some cases developing, novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A and nucleotide polymerase – as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.

Forward Looking Statements Disclaimer

This press release contains forward-looking statements, including with respect to AbbVie’s plans for announcing additional data regarding ABT-450 and ABT-493. 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 the actions of AbbVie (our collaborator on ABT-450 and ABT-493), regulatory actions affecting clinical development of ABT-450 and clinical development of competitive product candidates and clinical development of ABT-493. 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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