- 97-98 percent SVR12 achieved with eight
weeks of ABT-493 and ABT-530 treatment in genotypes 1, 2 or 3 HCV
patients without cirrhosis in SURVEYOR 1 and 2 studies1,2
- 100 percent SVR12 achieved with 12
weeks of treatment in difficult-to-treat genotype 3 patients with
compensated cirrhosis (Child-Pugh A) new to therapy 3
- 100 percent SVR12 achieved with 12
weeks of treatment in genotypes 4, 5 or 6 patients without
cirrhosiss; eight-week treatment duration being investigated in
this ongoing study4
- ABT-493 is Enanta’s second protease
inhibitor being developed in combination with ABT-530, AbbVie’s
NS5A 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 with eight weeks of treatment, 97-98 percent of
genotype 1, 2 or 3 (GT1-3) chronic hepatitis C virus (HCV) infected
patients without cirrhosis treated with AbbVie’s investigational,
once-daily, pan-genotypic regimen of ABT-493 and ABT-530, without
ribavirin (RBV), achieved sustained virologic response at 12 weeks
post-treatment (SVR12).1,2 Results for GT1 (n=33/34), GT2 (n=53/54)
and treatment-naïve GT3 (n=28/29) patients were based on an
Intent-to-Treat (ITT) analysis.1,2 Additionally, 100 percent
(n=34/34) of genotype 4, 5 or 6 (GT4-6) chronic HCV infected
patients without cirrhosis achieved SVR12 with 12 weeks of
treatment.4 These new data from the Phase 2 SURVEYOR-1 and
SURVEYOR-2 studies will be presented at The International Liver
Congress™ (ILC) 2016, in Barcelona, Spain.
In separate late-breaking data from the SURVEYOR-2 study, 100
percent of GT3 chronic HCV infected patients with compensated
cirrhosis (Child-Pugh A) and new to therapy achieved SVR12 with 12
weeks of treatment with or without RBV (n=24/24 in each arm).3 No
patients discontinued treatment due to adverse events. Data in GT3
chronic HCV infected patients with or without cirrhosis were
featured in the official ILC 2016 press program.
ABT-493 is Enanta’s second protease inhibitor being developed
through its collaboration with AbbVie and is one of the two new
direct-acting antivirals in the combination treatment being
investigated in the ongoing SURVEYOR-1 and SURVEYOR-2 studies.
“We are pleased that this ABT-493-containing regimen is
demonstrating high sustained virologic response rates across
multiple genotypes and without ribavirin,” commented Jay R. Luly,
Ph.D. President and Chief Executive Officer. “We are particularly
pleased with the results in genotype 1-3 patients with only 8 weeks
of treatment, as well as in difficult-to-treat genotype 3 patients
with compensated cirrhosis and 12 weeks of treatment. We look
forward to additional data later this year from AbbVie’s ongoing
phase 3 registrational program.”
In a pooled analysis of 531 patients across both SURVEYOR
studies of the five treatment regimens of ABT-493 and ABT-530
evaluated, the most commonly reported adverse events were fatigue
(18 percent), headache (17 percent), nausea (13 percent) and
diarrhea (10 percent).5 Three patients across all study arms
evaluated to date, two of whom received RBV, discontinued study
drugs early due to adverse events.5
Overview of SURVEYOR-1 and SURVEYOR-2
Clinical Data Presented at ILC:
PatientProfile/Study
Patient number (n)/Patient Population
Duration ofTreatment
TreatmentRegimen
SVR12 RatesITT *
GT1
Non-cirrhotic1
SURVEYOR-1
n=34
Treatment-naïve=85%
pegIFN/RBV treatmentexperienced=15%
8 weeks
ABT-493 (300mg) +ABT-530 (120mg)once
daily
97%
(n=33/34)
GT2
Non-cirrhotic1
SURVEYOR-2
n=54
Treatment-naïve=87%
pegIFN/RBV treatment
experienced=13%
8 weeks
ABT-493 (300mg) +ABT-530 (120mg)once
daily
98%(n=53/54)
GT3
Non-cirrhotic2
SURVEYOR-2
n=29Treatment-naïve =100%
8 weeks
ABT-493 (300mg) +ABT-530 (120mg)once
daily
97%(n=28/29)
GT3
Cirrhotic3 (Child-Pugh A)
SURVEYOR-2
n=24
Treatment-naïve= 100%
12 weeks
ABT-493 (300mg) +ABT-530 (120mg)(without
RBV)once daily
100%(n=24/24)
n=24Treatment-naïve= 100%
12 weeks
ABT-493 (300mg) +ABT-530 (120mg) +RBV
(800mg)once daily
100%(n=24/24)
GT 4,5,6
Non-cirrhotic4
SURVEYOR-1
n=34
(GT4=22; GT5=1; GT6=11)
Treatment-naïve=85%
pegIFN/RBV treatmentexperienced=15%
12 weeks
ABT-493 (300mg) +ABT-530 (120mg)once
daily
100%(n=34/34)
* Intent-to-treat (ITT) population is
defined as all patients who received at least one dose of the study
drugs
About SURVEYOR-11,4,5SURVEYOR-1 is an ongoing Phase 2,
two-part study designed to evaluate the safety and efficacy of
ABT-493 and ABT-530, with or without RBV, for eight or 12 weeks, in
cirrhotic and non-cirrhotic adult GT1 patients, and in
non-cirrhotic GT4, 5 or 6 adult patients, with chronic HCV
infection who were new to therapy or did not respond to previous
treatment with pegylated interferon (pegIFN)/RBV (null
responder).
About SURVEYOR-21,2,3,5SURVEYOR-2 is an ongoing Phase 2,
four-part study designed to evaluate the safety and efficacy of
ABT-493 and ABT-530, with or without RBV, in adult patients with
GT2, 3, 4, 5 or 6 chronic HCV infection who were new to therapy or
had failed previous treatment with pegylated interferon
(pegIFN)/RBV.
The primary endpoint of both studies is the percentage of
subjects achieving SVR12.
Safety and efficacy data for Part 1 of the studies were
presented at The Liver Meeting® 2015, the Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD) in San
Francisco.
About pooled safety analysis of SURVEYOR-1 and
SURVEYOR-25531 patients were included in this safety analysis:
26 percent GT1, 24 percent GT2, 43 percent GT3, and 6 percent with
GT4, 5, or 6 infection. Patients across genotypes received
ABT-493/ABT-530 at five doses: 300/120mg (n=258), 300/120mg with
RBV (n=27), 200/120mg (n=121), 200/120mg with RBV (n=56), and
200/40mg (n=69).
About EnantaEnanta 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 discovered 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 second NS5A
inhibitor. Enanta has also discovered a cyclophilin inhibitor,
EDP-494, a novel host-targeting 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 Enanta’s
programs and pipeline.
Forward Looking Statements DisclaimerThis press release
contains forward-looking statements, including statements with
respect to the prospects for AbbVie’s HCV investigational treatment
regimens containing ABT-493. Statements that are not historical
facts are based on management’s current expectations, estimates,
forecasts and projections about Enanta’s business and the industry
in which it operates and 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 and risks
that may affect actual results include: the efforts of AbbVie (our
collaborator developing ABT-493) to develop and obtain regulatory
approval of regimens containing ABT-493 and successfully
commercialize them; the development, regulatory and marketing
efforts of others with respect to competitive HCV treatment
regimens; regulatory and reimbursement actions affecting any
ABT-493-containing regimen, any competitive regimen, or both; 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 any 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.
_____________________________________
1 Poordad, F et al. 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. Poster presentation #SAT-157; presented
at The International Liver Congress™ (ILC), the Annual Meeting of
the European Association for the Study of the Liver (EASL) in
Barcelona, Spain, April 13-17, 2016.
2 Muir, A et al. High SVR Rates with ABT-493 + ABT-530
Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV
Genotype 3 Infection. Oral presentation #PS098; presented at The
International Liver Congress™ (ILC), the Annual Meeting of the
European Association for the Study of the Liver (EASL) in
Barcelona, Spain, April 13-17, 2016.
3 Kwo, P et al. 100% SVR4 With ABT-493 and ABT-530 With or
Without Ribavirin in Treatment-naïve HCV Genotype 3-infected
Patients With Cirrhosis; Late Breaker presentation #LB01; presented
at The International Liver Congress™ (ILC), the Annual Meeting of
the European Association for the Study of the Liver (EASL) in
Barcelona, Spain, April 13-17, 2016
4 Gane, E et al. 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). Poster presentation
#SAT-137; presented at The International Liver Congress™ (ILC), the
Annual Meeting of the European Association for the Study of the
Liver (EASL) in Barcelona, Spain, April 13-17, 2016.
5 Kwo, P et al. 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; Poster presentation #SAT-239;
presented at The International Liver Congress™ (ILC), the Annual
Meeting of the European Association for the Study of the Liver
(EASL) in Barcelona, Spain, April 13-17, 2016.
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version on businesswire.com: http://www.businesswire.com/news/home/20160415005972/en/
Enanta Pharmaceuticals, Inc.Investor ContactCarol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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