- Results confirm previously reported
data in genotype 1 (GT1) patient populations demonstrating high
sustained virologic response rates at 12 weeks post-treatment
(SVR12)
- Results demonstrate SVR12 of 97 to 100%
in GT1b patients
- SVR12 of 92 to 96% was shown in the
difficult-to-treat GT1 cirrhotic patient population
- AbbVie announced it expects U.S. launch
in 2014
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) today announced
results from the PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II
studies. These studies are the remaining four phase 3 studies of
the six phase 3 registrational studies being conducted by AbbVie
for the treatment of genotype 1 (GT1) hepatitis C virus (HCV)
infection using a regimen containing Enanta’s lead protease
inhibitor ABT-450. ABT-450 is part of AbbVie’s investigational
three direct-acting antiviral regimen consisting of boosted
protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and
non-nucleoside polymerase inhibitor ABT-333. These studies were
conducted with and without ribavirin. The combination of the three
different mechanisms of action in this regimen interrupts the HCV
replication process with the goal of optimizing SVR rates across
different patient populations.
Results from these studies demonstrate high sustained virologic
response rates 12 weeks post treatment (SVR12) and tolerability in
these GT1 patients and low rates of discontinuation due to adverse
events.
A summary of AbbVie’s Phase 3 clinical trial results for the 3D
regimen consisting of ABT-450/ritonavir, ABT-267 and ABT-333
follows:
Study Patient Type (number)
Treatment Regimen
TreatmentDuration SVR12
PEARL-II
GT1b treatment-experienced(n=179)
12 week 100%
- 3D regimen with ribavirin(n=88)
12 weeks 97% PEARL-III
GT1b, treatment-naïve(n=419)
12 weeks 99%
- 3D regimen with ribavirin(n=210)
12 weeks 99% PEARL-IV
GT1a, treatment-naïve(n=305)
12 weeks 90%
- 3D regimen with ribavirin(n=100)
12 weeks 97% TURQUOISE-II
GT1 treatment-naïve and
treatment-experienced with compensatedcirrhosis (n=380)
- 3D regimen with ribavirin(n=208)
12 weeks 92%
- 3D regimen with ribavirin(n=172)
24 weeks 96% SAPPHIRE-I
GT1 treatment-naïve(n=631)
- 3D regimen with ribavirin(n=473)
12 weeks 96% SAPPHIRE-II
GT1 treatment-experienced(n=394)
- 3D regimen with ribavirin(n=297)
12 weeks 96%
Overall, across the four studies, the three direct-acting
antiviral regimen was well tolerated with few adverse event-related
discontinuations. The most commonly reported adverse events in
PEARL-II and PEARL-III were fatigue and headache. In PEARL-IV and
TURQUOISE-II, the most commonly reported adverse events were
fatigue, headache and nausea.
“We are pleased that SVR rates continue to be high in both
treatment-naive and treatment-experienced GT1 HCV patients with and
without ribavirin, as well as in the difficult-to-treat compensated
cirrhotic patients. In addition, these trials demonstrate the
exceptional tolerability of the regimen, with less than one percent
(0.8%) of patients discontinuing therapy due to adverse events,”
said Jay R. Luly, Ph.D. President and CEO. “We are also pleased
that AbbVie has announced it is on track to begin major regulatory
submissions early in the second quarter of 2014.”
These six phase 3 trials included 2,308 patients from more than
25 countries around the world. This is the only registrational
program to include a dedicated study of an all-oral regimen in
patients with compensated cirrhosis. In May 2013, AbbVie’s three
direct-acting antiviral regimen with and without ribavirin for GT1
HCV was designated as a Breakthrough Therapy by the U.S. Food and
Drug Administration (FDA). AbbVie has stated that it intends to
disclose detailed study results at future scientific congresses and
in publications.
About Study M13-389 (PEARL-II)
PEARL-II is a global, multi-center, randomized, open-label,
controlled study to evaluate the efficacy and safety of 12 weeks of
treatment with the three direct-acting antiviral regimen with and
without ribavirin in non-cirrhotic, GT1b HCV-infected,
treatment-experienced adult patients.
The study population consisted of 179 GT1b treatment-experienced
patients with no evidence of liver cirrhosis: 91 patients were
randomized to the regimen without ribavirin for 12 weeks, and 88
patients were randomized to the regimen plus ribavirin for 12
weeks. In the ribavirin-free arm, 100 percent (n=91/91) of patients
achieved SVR12, while 97 percent (n=85/88) achieved SVR12 in the
ribavirin-containing arm.
The most commonly reported adverse events were fatigue and
headache. Discontinuations due to adverse events were reported in
none of the patients in the ribavirin-free arm and two (2 percent)
patients in the ribavirin-containing arm. There were no patients in
either arm of the study that experienced virologic relapse or
breakthrough.
About Study M13-961 (PEARL-III)
PEARL-III is a global, multi-center, randomized, double-blind,
controlled study to evaluate the efficacy and safety of 12 weeks of
treatment with the three direct-acting antiviral regimen with and
without ribavirin in non-cirrhotic, GT1b HCV-infected,
treatment-naïve adult patients.
The study population consisted of 419 GT1b treatment-naïve
patients with no evidence of liver cirrhosis; 209 patients were
randomized to the regimen without ribavirin for 12 weeks, and 210
patients were randomized to the regimen plus ribavirin for 12
weeks. Following 12 weeks of treatment, 99 percent receiving the
regimen without ribavirin (n=207/209) and 99 percent receiving the
regimen plus ribavirin (n=209/210) achieved SVR12.
The most commonly reported adverse events were fatigue and
headache. No patient discontinued study drug due to adverse events.
Virologic relapse or breakthrough was noted in none of the patients
receiving the regimen without ribavirin and 0.5 percent of patients
receiving the regimen plus ribavirin.
About Study M14-002 (PEARL-IV)
PEARL-IV 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 and without ribavirin in non-cirrhotic, GT1a HCV-infected,
treatment-naïve adult patients.
The study population consisted of 305 GT1a treatment-naïve
patients with no evidence of liver cirrhosis; 205 patients were
randomized to the regimen without ribavirin for 12 weeks, and 100
patients were randomized to the regimen with ribavirin for 12
weeks. Following 12 weeks of treatment, 90 percent of patients
receiving the regimen without ribavirin (n=185/205) and 97 percent
receiving the regimen plus ribavirin (n=97/100) achieved SVR12.
The most commonly reported adverse events were fatigue, headache
and nausea. Discontinuations due to adverse events were reported in
two (1 percent) patients receiving the regimen without ribavirin
and no patients in the ribavirin-containing arm. Virologic relapse
or breakthrough was noted in 8 percent of patients receiving the
regimen without ribavirin and 2 percent of patients receiving the
regimen with ribavirin.
About Study M13-099 (TURQUOISE-II)
TURQUOISE-II is the first phase III study completed exclusively
in GT1 cirrhotic patients investigating an all-oral interferon-free
regimen. It is a global, multi-center, randomized, open-label study
evaluating the efficacy and safety of 12 or 24 weeks of treatment
with the three direct-acting antiviral regimen with ribavirin in
cirrhotic, GT1a and GT1b HCV-infected, treatment-naïve and
treatment-experienced adult patients.
The study population consisted of 380 GT1a and GT1b,
treatment-naïve and treatment-experienced patients with compensated
cirrhosis; 208 patients were randomized to the regimen plus
ribavirin for 12 weeks, and 172 patients were randomized to the
regimen plus ribavirin for 24 weeks. Following 12 weeks of
treatment, 92 percent of patients (n=191/208) achieved SVR12.
Following 24 weeks of treatment, 96 percent of patients (n=165/172)
achieved SVR12.
The most commonly reported adverse events were fatigue, headache
and nausea. Discontinuations due to adverse events were reported in
four (2 percent) patients receiving the regimen with ribavirin for
12 weeks and four (2 percent) patients in the 24-week arm.
Virologic relapse or breakthrough was noted in 6 percent of
patients in the 12-week arm and 2 percent in the 24-week arm.
Additional information about AbbVie’s phase 3 studies can be
found on www.clinicaltrials.gov.
Protease Inhibitor Collaboration with AbbVie (formerly the
research-based pharmaceutical business of Abbott
Laboratories)
In December 2006, Enanta and Abbott announced a worldwide
agreement to collaborate on the discovery, development and
commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV
protease inhibitor-containing drug combinations. ABT-450 is a
protease inhibitor identified as a lead compound through the
collaboration. Under the agreement, AbbVie is responsible for all
development and commercialization activities for ABT-450. Enanta
received $57 million in connection with signing the collaboration
agreement, has received $55 million in subsequent clinical
milestone payments, and is eligible to receive an additional $195
million in payments for regulatory milestones, as well as
double-digit royalties worldwide on any revenue allocable to the
collaboration’s protease inhibitors. Also, for any additional
collaborative HCV protease inhibitor product candidate developed
under the agreement, Enanta holds an option to modify the U.S.
portion of it rights to receive milestone payments and worldwide
royalties. With this option, Enanta can fund 40 percent of U.S.
development costs and U.S. commercialization efforts (sales and
promotion costs) for the additional protease inhibitor in exchange
for 40 percent of any U.S. profits ultimately achieved after
regulatory approval, instead of receiving payments for U.S.
commercial regulatory approval milestones and royalties on U.S.
sales of that protease inhibitor.
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 with respect to the clinical data and the planned
regulatory submissions for the three direct-acting antiviral HCV
treatment regimen containing ABT-450. 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 final results of
ongoing clinical trials of the three direct-acting antiviral
ABT-450-containing regimen, the development, regulatory and
marketing efforts of AbbVie (our collaborator on ABT-450), clinical
development of competitive product candidates, regulatory
submissions by AbbVie and its competitors in HCV and regulatory
actions affecting the three direct-acting antiviral
ABT-450-containing regimen and competitive regimens. 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.
Enanta Pharmaceuticals, Inc.Investor:Carol
Miceli, 617-607-0710cmiceli@enanta.comMedia:Kari
Watson, 781-235-3060MacDougall Biomedical
Communicationskwatson@macbiocom.com
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