Enanta Pharmaceuticals Announces Detailed Data from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis being P...
April 12 2014 - 1:04AM
Business Wire
- In patients with compensated liver
cirrhosis and genotype 1 (GT1) chronic hepatitis C virus,
TURQUOISE-II demonstrated SVR12 rates of 91.8% and 95.9% after 12
and 24 weeks of treatment, respectively
- TURQUOISE-II is the largest phase 3,
all-oral, Interferon-free study in cirrhotic patients with
hepatitis C virus conducted to date
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 detailed results from AbbVie’s pivotal phase 3
TURQUOISE-II study, will be presented as a late-breaking oral
presentation today at the International Liver Congress (ILC), which
is the 49th Annual Meeting of the European Association for the
Study of the Liver (EASL). Results from the TURQUOISE-II study were
featured in the ILC press conference yesterday and were published
on-line in the New England Journal of Medicine.
The TURQUOISE-II study reports results from AbbVie’s
investigational three direct-acting antiviral regimen containing
ABT-450, Enanta’s lead protease inhibitor discovered through
Enanta’s collaboration with AbbVie. The regimen consists of boosted
protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and
non-nucleoside polymerase inhibitor ABT-333.
TURQUOISE-II is a global, multi-center, randomized, open-label
study evaluating the efficacy and safety of 12 weeks or 24 weeks of
treatment with AbbVie's three direct-acting antiviral regimen with
ribavirin (RBV) in adult patients with genotype 1 (GT1) chronic
hepatitis C virus (HCV) infection with compensated liver cirrhosis.
Patients achieved sustained virologic response rates 12 weeks
post-treatment (SVR12) of 91.8 percent and 95.9 percent in the
12-week and 24-week treatment arms, respectively. Patients in the
study were either new to therapy or treatment-experienced (failed
previous treatment with pegylated interferon and RBV).
TURQUOISE-II Results
12-Week Arm SVR12
(n=208)
24-Week Arm SVR12
(n=172)
All GT1 91.8%
(n=191/208) 95.9% (n=165/172)
GT1a 88.6% (n=124/140)
94.2% (n=114/121) New to
therapy 92.2% (n=59/64)
92.9% (n=52/56) GT1a treatment-experienced
Prior null responders 80.0% (n=
40/50) 92.9% (n=39/42)
Prior relapsers 93.3% (n= 14/15)
100.0% (n=13/13) Prior partial
responders 100.0% (n= 11/11)
100.0% (n=10/10) GT1b
98.5% (n=67/68) 100.0% (n=51/51)
New to therapy 100.0% (n= 22/22)
100.0% (n=18/18) GT1b
treatment-experienced
Prior null responders
100.0% (n=14/14)
100.0% (n=10/10) Prior
relapsers 100.0% (n=25/25)
100.0% (n=20/20) Prior partial
responders 85.7% (n= 6/7)
100.0% (n=3/3)
Discontinuation rates due to adverse events were 1.9 percent
(four patients) and 2.3 percent (four patients) in the 12-week and
24-week arms, respectively. The most commonly reported adverse
events (>10 percent in either arm) in TURQUOISE-II were fatigue,
headache, nausea, pruritus, insomnia, diarrhea, asthenia, rash,
cough, irritability, anemia and dyspnea.
On-treatment virologic failure occurred in one patient (0.5
percent) in the 12-week arm and three patients (1.7 percent) in the
24-week arm. In addition, 12 patients (5.9 percent) in the 12-week
arm and one patient (0.6 percent) in the 24-week arm experienced
relapse within 12 weeks post-treatment.
“Data presented to date from AbbVie’s three direct-acting
antiviral regimen with and without ribavirin have demonstrated high
SVR rates across a range of GT1 patient populations,” said Jay R.
Luly, Ph.D., President and CEO. “In addition, the positive results
from the TURQUOISE-II study have demonstrated that this regimen
with ribavirin provides high SVR rates in the difficult-to-treat,
cirrhotic GT1 patients.”
Additional results from studies using AbbVie’s
three-direct-acting antiviral regimen containing ABT-450 being
presented at the ILC today include:
- PEARL-III late-breaker poster: A phase
3 study examining the regimen for 12 weeks with or without RBV in
non-cirrhotic GT1b HCV-infected adult patients who were new to
therapy.
- M12-999 oral presentation: Interim
results of a phase II examining the regimen with RBV for 24 weeks
in non-cirrhotic liver transplant recipients with recurrent GT1 HCV
infection
Additional information about AbbVie’s phase III studies can be
found on www.clinicaltrials.gov.
About ABT-450
ABT-450 is an NS3 protease inhibitor discovered through Enanta’s
collaboration with AbbVie. AbbVie and Enanta have an agreement to
collaborate on the discovery, development and commercialization of
HCV NS3 and NS3/4A protease inhibitors. Protease inhibitors play an
essential role in the viral life cycle of the hepatitis C virus
(HCV). Inhibition of the protease prevents non-structural (NS)
proteins from forming and thereby prevents replication and survival
of the HCV virus. ABT-450 is part of AbbVie’s investigational
regimen for HCV that consists of boosted protease inhibitor
ABT-450/ritonavir (referred to as ABT-450/r), NS5A inhibitor
ABT-267 and non-nucleoside polymerase inhibitor ABT-333.
About Hepatitis C Virus (HCV)
Hepatitis C is a liver disease affecting over 170 million people
worldwide. The virus is typically spread through direct contact
with the blood of an infected person. Hepatitis C increases a
person’s risk of developing chronic liver disease, cirrhosis, liver
cancer and death. Patients with compensated cirrhosis have a liver
that is heavily scarred but that can still perform many important
bodily functions with few or no symptoms. There is an acute need
for new HCV therapies that are safer and more effective for many
variants of the virus.
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 (partnered with Novartis) 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 statements with respect to the prospects for AbbVie’s HCV
treatment regimen containing ABT-450 that is being developed as a
potential treatment across a range of GT1 patient populations.
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-450) to
obtain regulatory approvals and commercialize treatment regimens
containing ABT-450, the development, regulatory and marketing
efforts of others with respect to competitive treatment regimens,
regulatory actions affecting any ABT-450-containing regimen, any
competitive regimen, or both, and the level of market acceptance
and the rate of reimbursement for any ABT-450-containing regimen.
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
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