Enanta Pharmaceuticals Announces Data Presentations on Regimens Containing ABT-450 or ABT-493 to be Presented at the American...
October 01 2014 - 10:06AM
Business Wire
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 CharacteristicsM.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
RibavirinG.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
RibavirinP.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 SubjectsJeffrey 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
FunctionA. 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 ResistanceT. 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 InfectionE. 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
CirrhosisChih-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 ResultsS. 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 RibavirinM. 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 RibavirinD.
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
RibavirinI.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 trialsP.
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 TrialsM.
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 RibavirinD.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
RibavirinM.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
TrialsM.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 TrialsD. 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 ± ribavirinG.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
InfectionP. 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 IVJ.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 CirrhosisM.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
RibavirinJ.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 TrialsS.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 TrialsD.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.
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Feb 2024 to Mar 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Mar 2023 to Mar 2024