- SVR12 rates of 96% were demonstrated in
both treatment-naïve and treatment-experienced genotype 1 (GT1)
patients with chronic hepatitis C virus
- SVR12 rates of 95% to 100% were
demonstrated in treatment-experienced GT1 patient sub-populations
(SAPPHIRE-II)
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
SAPPHIRE-I study, will be presented today at the International
Liver Congress (ILC), which is the 49th Annual Meeting of the
European Association for the Study of the Liver (EASL) and featured
in the ILC press conference. Results from the SAPPHIRE-II study
were presented at the congress yesterday. Additionally, results
from both the SAPPHIRE-I and SAPPHIRE-II studies have been
published on-line in the New England Journal of Medicine.
The SAPPHIRE-I and SAPPHIRE-II studies report results from
AbbVie’s investigational three direct-acting antiviral regimen
containing ABT-450, Enanta’s lead protease inhibitor developed
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.
In the SAPPHIRE-I (N=631) and SAPPHIRE-II (N=394)
placebo-controlled studies, adult, non-cirrhotic patients with
chronic genotype 1 (GT1) hepatitis C virus (HCV) infection
receiving the investigational three-direct-acting antiviral regimen
with ribavirin (RBV) for 12 weeks achieved sustained virologic
response rates 12 weeks post-treatment (SVR12) of 96.2 percent
(n=455/473) and 96.3 percent (n=286/297), respectively.
In SAPPHIRE-II, treatment-experienced sub-populations randomized
to the three direct-acting antiviral regimen with RBV in the study
were prior null responders (49.2 percent), prior relapsers (29.0
percent) and prior partial responders (21.9 percent) to pegylated
interferon and RBV.
SAPPHIRE-I and SAPPHIRE-II
Results
SAPPHIRE-I SVR12
(n=473)
SAPPHIRE-II SVR12
(n=297)
All GT1 96.2% (n=455/473)
96.3% (n=286/297)* GT1a
95.3% (n=307/322)
96.0% (n=166/173) GT1b 98.0%
(n=148/151) 96.7% (n=119/123)
Treatment-experienced (GT1a and GT1b) Prior null responders
n/a 95.2%
(n=139/146) Prior relapsers n/a
95.3% (n=82/86) Prior partial responders
n/a 100.0%
(n=65/65)
*Subgenotype could not be determined for one patient
In SAPPHIRE-I, high response rates were seen across patients
with certain variable characteristics, including gender, race, body
mass index, fibrosis stage and baseline HCV viral load, as some of
these patients have historically had a reduced response to
treatment.
Discontinuations due to adverse events were reported in 0.6
percent of patients in both arms in SAPPHIRE-I and in 1.0 percent
of patients receiving the AbbVie regimen in SAPPHIRE-II and no
patients receiving placebo. The most commonly reported
treatment-emergent adverse events (>10 percent in either arm)
for both SAPPHIRE-I and SAPPHIRE-II were fatigue, headache, nausea,
asthenia, insomnia, pruritus and diarrhea. Additional common
adverse events occurring in the studies were rash in SAPPHIRE-I and
dyspnea, cough and myalgia in SAPPHIRE-II. In SAPPHIRE-I, the
adverse events that occurred with a significantly greater frequency
in the treatment arm compared to placebo were pruritus, insomnia,
diarrhea, nausea and asthenia; in SAPPHIRE-II, only pruritus.
About Study M11-646 (SAPPHIRE-I)
SAPPHIRE-I is a global, multi-center, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of 12
weeks of treatment with the three direct-acting antiviral regimen
with RBV in non-cirrhotic, GT1a and GT1b HCV-infected adult
patients new to therapy.
The study population consisted of 631 patients: 473 were
randomized to the three direct-acting antiviral regimen with RBV
for 12 weeks, and 158 patients were randomized to placebo for the
initial 12 weeks. Patients initially randomized to placebo for the
first 12 weeks then received open-label treatment with the AbbVie
regimen with RBV for 12 weeks.
Of the 473 patients randomized to the three direct-acting
antiviral regimen with RBV, one case (0.2 percent) of on-treatment
virologic failure occurred and seven patients (1.5 percent)
experienced post-treatment relapse. In addition, three patients
(0.6 percent) were lost to follow-up and seven patients (1.5
percent) discontinued the study prematurely. Patients lost to
follow-up were considered treatment failures.
About Study M13-098 (SAPPHIRE-II)
SAPPHIRE-II is a global, multi-center, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of 12
weeks of treatment with the three direct-acting antiviral regimen
with RBV in non-cirrhotic, GT1a and GT1b HCV-infected,
treatment-experienced adult patients who previously failed
treatment with pegylated interferon and RBV.
The study population consisted of 394 patients: 297 were
randomized to the three direct-acting antiviral regimen with RBV
for 12 weeks, and 97 patients were randomized to placebo for the
initial 12 weeks. Patients initially randomized to placebo for the
first 12 weeks then received open-label treatment with the three
direct-acting antiviral regimen with RBV for 12 weeks.
Of the 297 patients randomized to the three direct-acting
antiviral regimen with RBV, there were no cases of on-treatment
virologic failure and seven patients (2.4 percent) experienced
post-treatment relapse. Of these patients, six were prior null
responders and one was a prior relapser. Three patients (1.0
percent) prematurely discontinued therapy due to adverse events and
one patient (0.3 percent) prematurely discontinued the study.
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 Disclaimers
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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