Preliminary SVR4 Data of 99 percent
Announced on Phase 2b regimens containing ABT-493 and
ABT-530
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases,
announced today abstracts of research on regimens containing either
one of Enanta’s two protease inhibitors for hepatitis C virus (HCV)
identified and developed in its ongoing collaboration with AbbVie,
have been accepted for presentation at The International Liver
Congress (ILC), which is the 50th Annual Meeting of the European
Association for the Study of the Liver (EASL) taking place in
Vienna April 22-26, 2015. Paritaprevir, Enanta’s lead protease
inhibitor, is included in AbbVie’s HCV treatment regimens approved
in the U.S. in late 2014 and in the E.U. in early 2015. ABT-493,
the collaboration’s next-generation protease inhibitor currently in
phase 2b clinical studies, is being developed by AbbVie in
combination with ABT-530, AbbVie’s next generation NS5A inhibitor,
for pan-genotypic treatment of HCV.
Enanta also announced that AbbVie reported preliminary results
from a Phase 2b study (n=79) of ABT-493 and ABT-530 combination
treatments in non-cirrhotic genotype 1 HCV patients receiving the
ribavirin (RBV)-free, once-daily regimen for 12 weeks demonstrated
a sustained virologic response rate at four weeks post treatment
(SVR4) of 99 percent (n=78/79). These results announced for the
first time today included both GT1a and GT1b, treatment-naïve and
pegylated-interferon and RBV prior null responders. Patients across
both study arms were randomized to receive ABT-493 (200mg) and
either 120mg or 40mg of ABT-530. To date, the most common (>5
percent) adverse reactions were fatigue, headache, nausea, diarrhea
and anxiety. Data from these Phase 2b studies of ABT-493 and
ABT-530 combinations will not be presented at ILC 2015, but are
expected to be released at future medical congresses. AbbVie’s
ongoing development program investigating a pan-genotypic, RBV-free
treatment regimen containing ABT-493 may allow for treatment
durations of as little as 8 weeks.
The following list of paritaprevir-related and ABT-493-related
e-poster, oral presentations and abstracts can now be viewed at the
EASL website at www.easl.eu.
Oral Presentations:Friday, April 24, 20154:15 - 4:30 p.m.
CEST#O057: LONG-TERM FOLLOW-UP OF TREATMENT-EMERGENT
RESISTANCE-ASSOCIATED VARIANTS IN NS3, NS5A AND NS5B WITH
PARITAPREVIR/R-, OMBITASVIR- AND DASABUVIR-BASED REGIMENSPresenter:
Preethi Krishnan
Saturday, April 25, 201508:30 - 08:45 a.m. CEST#G13:
OMBITASVIR/PARITAPREVIR/RITONAVIR FOR TREATMENT OF HCV GENOTYPE 1B
IN JAPANESE PATIENTS WITH OR WITHOUT CIRRHOSIS: RESULTS FROM
GIFT-IPresenter: Ken Sato
Late Breakers SessionSaturday April 25, 20154:00 - 4:15
p.m. CESTSAFETY OF OMBITASVIR/PARITAPREVIR/RITONAVIR PLUS DASABUVIR
FOR TREATING HCV GT1 INFECTION IN PATIENTS WITH SEVERE RENAL
IMPAIRMENT OR END-STAGE RENAL DISEASE: THE RUBY-I STUDYPresenter:
Paul Pockros
E-Poster Presentations:
ABT-493P0715: STEADY-STATE PHARMACOKINETICS AND SAFETY OF
COADMINISTRATION OF PAN-GENOTYPIC, DIRECT ACTING PROTEASE
INHIBITOR, ABT-493 WITH PAN-GENOTYPIC NS5A INHIBITOR, ABT-530, IN
HEALTHY ADULT SUBJECTSPresenter: Chih-Wei Lin
P0855: PHARMACOKINETICS OF ABT-493 AND ABT-530 IS SIMILAR IN
HEALTHY CAUCASIAN, CHINESE, AND JAPANESE ADULT SUBJECTSPresenter:
Tianli Wang
Paritaprevir
LP39: IMPLICATIONS OF BASELINE HCV RNA LEVEL AND INTRAPATIENT
VIRAL LOAD VARIABILITY ON OBV/PTV/R + DSV 12-WEEK TREATMENT
OUTCOMESPresenter: Robert Brown
P0781: HIGH SVR RATES DESPITE MULTIPLE NEGATIVE PREDICTORS IN
GENOTYPE 1 PATIENTS RECEIVING OMBITASVIR/PARITAPREVIR/R, DASABUVIR
WITH OR WITHOUT RIBAVIRIN FOR 12 AND 24 WEEKS: INTEGRATED ANALYSIS
OF SIX PHASE 3 TRIALSPresenter: David Bernstein
P0806: THE VALUE OF SURVIVAL BENEFITS FROM TREATING HEPATITIS C
AT DIFFERENT FIBROSIS STAGES WITH ALL-ORAL, INTERFERON-FREE THERAPY
RELATIVE TO ‘WATCHFUL WAITING’Presenter: Yuri Sanchez Gonzalez
P0808: IMPROVEMENT IN LIVER FUNCTION AND NON-INVASIVE ESTIMATES
OF LIVER FIBROSIS 48 WEEKS AFTER TREATMENT WITH
OMBITASVIR/PARITAPREVIR/R, DASABUVIR AND RIBAVIRIN IN HCV GENOTYPE
1 PATIENTS WITH CIRRHOSISPresenter: Heiner Wedemeyer
P0815: COST-EFFECTIVENESS OF TREATING DIFFERENT STAGES OF
GENOTYPE 1 HEPATITIS C VIRUS (HCV) WITH ABBVIE 3D
(ABT-450/RITONAVIR/OMBITASVIR AND DASABUVIR) +/- RIBAVIRIN COMPARED
TO NO TREATMENT IN THE UNITED STATESPresenter: Jennifer C. Samp
P0816: REDUCTION IN ANNUAL MEDICAL COSTS WITH EARLY TREATMENT OF
HCV USING ABBVIE 3D (ABT-450/RITONAVIR/OMBITASVIR AND DASABUVIR)
+/- RIBAVIRIN IN THE UNITED STATESPresenter: Jennifer C. Samp
P0820: PHARMACOKINETICS OF PARITAPREVIR, OMBITASVIR, DASABUVIR,
RITONAVIR AND RIBAVIRIN IN SUBJECTS WITH HCV GENOTYPE 1 INFECTION
IN PHASE 3 STUDIESPresenter: Sven Mensing, Amit Khatri
P0823: PHARMACOKINETICS OF PARITAPREVIR, OMBITASVIR, RITONAVIR
AND RIBAVIRIN IN SUBJECTS WITH HCV GENOTYPE 4 INFECTIONPresenter:
D�rthe Eckert
P0842: MALACHITE-I: PHASE 3B TRIAL OF OMBITASVIR/PARITAPREVIR/R
AND DASABUVIR +/-RIBAVIRIN OR TELAPREVIR + PEGINTERFERON/RIBAVIRIN
IN TREATMENT-NAÏVE ADULTS WITH HCV GENOTYPE 1Presenter: Brian
Conway
P0847: MALACHITE-II: PHASE 3B TRIAL OF OMBITASVIR/PARITAPREVIR/R
AND DASABUVIR + RIBAVIRIN OR TELAPREVIR + PEGINTERFERON/RIBAVIRIN
IN PEGINTERFERON/RIBAVIRIN TREATMENT-EXPERIENCED ADULTS WITH HCV
GENOTYPE 1Presenter: Gregory Dore
P0850: PERCENT OF SUBJECTS EXPERIENCING LIVER MORBIDITY OVER A
LIFETIME HORIZON WITH ABBVIE 3D (ABT-450/RITONAVIR/OMBITASVIR AND
DASABUVIR) VERSUS NO TREATMENTPresenter: Jennifer C. Samp
P0856: OMBITASVIR/PARITAPREVIR/RITONAVIR AND DASABUVIR WITH
RIBAVIRIN (RBV) HAS MILD IMPACT ON HEALTH-RELATED QUALITY OF LIFE
(HRQOL) COMPARED WITH PLACEBO DURING 12-WEEK TREATMENT IN
TREATMENT-EXPERIENCED ADULTS WITH CHRONIC HEPATITIS C
(CHC)Presenter: Yan Liu
P0873: OMBITASVIR/PARITAPREVIR/RITONAVIR AND DASABUVIR WITH
RIBAVIRIN (RBV) HAS MINIMAL IMPACT ON HEALTH-RELATED QUALITY OF
LIFE (HRQOL) COMPARED WITH PLACEBO DURING 12-WEEK TREATMENT IN
TREATMENT-NAÏVE ADULTS WITH CHRONIC HEPATITIS C (CHC)Presenter: Yan
Liu
P0902: EXPOSURE-RESPONSE ANALYSES FOR EFFICACY (SVR12) FOR THE
DIRECT ACTING ANTIVIRAL REGIMEN OF ABT-450/R, OMBITASVIR WITH
DASABUVIR ± RIBAVIRIN IN SUBJECTS WITH HCV GENOTYPE 1
INFECTIONPresenter: Amit Khatri
P0905: NO SIGNIFICANT INTERACTION AMONG
OMBITASVIR/PARITAPREVIR/RITONAVIR ± DASABUVIR AND
SOFOSBUVIRPresenter: Jennifer King
P0908: ADHERENCE TO OMBITASVIR/PARITAPREVIR/R, DASABUVIR, AND
RIBAVIRIN IS >98% IN THE SAPPHIRE-I AND SAPPHIRE-II
TRIALSPresenter: Tarek Hassanein
P1245: PUBLIC HEALTH IMPACT OF HCV SCREENING AND TREATMENT IN
THE FRENCH BABY-BOOMER POPULATIONPresenter: Olivier Ethgen
P1331: PHASE 3B STUDIES TO ASSESS LONG-TERM CLINICAL OUTCOMES IN
HCV GT1-INFECTED PATIENTS TREATED WITH
OMBITASVIR/PARITAPREVIR/RITONAVIR AND DASABUVIR WITH OR WITHOUT
RIBAVIRINPresenter: Emily O. Dumas
P1345: A RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE EFFICACY AND
SAFETY OF OMBITASVIR/PARITAPREVIR/RITONAVIR CO-ADMINISTERED WITH
RIBAVIRIN IN ADULTS WITH GENOTYPE 4 CHRONIC HEPATITIS C INFECTION
AND CIRRHOSISPresenter: Tarik Asselah
P1351: AN OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY
OF CO-FORMULATED OMBITASVIR/PARITAPREVIR/RITONAVIR WITH RIBAVIRIN
IN ADULTS WITH CHRONIC HCV GENOTYPE 4 INFECTION IN EGYPTPresenter:
Wahid Doss
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for AbbVie’s HCV
treatment regimens containing ABT-493 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) to develop and obtain
regulatory approvals and commercialize treatment regimens
containing ABT-493; the development, regulatory and marketing
efforts of others with respect to competitive HCV treatment
regimens; regulatory and reimbursement actions affecting any
ABT-493-containing regimens, any competitive regimens, or both; the
level of market acceptance and the pricing and rate of
reimbursement for any ABT-493-containing regimens; 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, 2014 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.
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 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. Enanta’s lead
protease inhibitor, paritaprevir, is part of AbbVie’s recently
approved HCV treatment regimens. In addition, Enanta has a
preclinical program in non-alcoholic steatohepatitis, or NASH,
which is a condition that results in liver inflammation and damage
caused by a buildup of fat in the liver.
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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