- AbbVie reports 98 percent of previously
untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV)
infected patients without cirrhosis achieved SVR12 in Phase 3b
GARNET study1
- First study evaluating 8 weeks of
VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA
(dasabuvir tablets)1
- GT1b is the most common HCV subtype
globally2, accounting for approximately 47 percent of the estimated
nine million people infected with chronic HCV in Europe
alone3,4
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 new data showing high response rates with just eight
weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) +
EXVIERA® (dasabuvir tablets) treatment. VIEKIRAX + EXVIERA is
currently approved in the European Union for GT1b patients without
cirrhosis or with compensated cirrhosis for 12 weeks.
In AbbVie’s Phase 3b GARNET study, 98 percent (n=160/163) of
previously untreated patients with genotype 1b (GT1b) chronic
hepatitis C virus (HCV) infection without cirrhosis achieved
sustained virologic response rates at 12 weeks post-treatment
(SVR12).1 These data were presented today at the 2016 EASL Special
Conference: New Perspectives in Hepatitis C Virus Infection – The
Roadmap for Cure, in Paris, France and included in the newly
published ‘EASL Recommendations on Treatment of Hepatitis C.’
Paritaprevir is Enanta’s lead protease inhibitor identified
within the ongoing Enanta-AbbVie collaboration and is one of the
direct-acting antivirals in AbbVie’s VIEKIRAX + EXVIERA treatment
regimen for chronic hepatitis C virus (HCV).
In 2016, the World Health Organization has estimated that
130-150 million people worldwide are infected with HCV.5 In Europe,
GT1b is the predominant genotype, accounting for approximately 47
percent of the estimated nine million Europeans infected with
chronic HCV.3,4,6
In the GARNET study, the most commonly reported adverse events
(≥5 percent) were headache (21 percent), fatigue (17 percent),
nasopharyngitis (8 percent), pruritus (8 percent), nausea (6
percent) and asthenia (5 percent). These adverse events were mostly
mild, with one patient discontinuing treatment due to adverse
events.1
About the GARNET Study1The Phase 3b GARNET study
is a multicenter, open-label, single-arm study, investigating the
safety and efficacy of eight weeks of treatment with VIEKIRAX +
EXVIERA without ribavirin in treatment-naïve patients with GT1b
chronic HCV infection without cirrhosis.1 The study enrolled 166
patients across 20 sites around the world. Of the 166 patients
enrolled, 163 patients had GT1b chronic HCV infection without
cirrhosis and three patients with other HCV genotypes were excluded
from the efficacy analysis. The primary endpoint is the percentage
of patients who achieved a sustained virologic response 12 weeks
after treatment (SVR12).
Two patients experienced post-treatment relapse and one subject
discontinued due to noncompliance. Less than one percent of
patients experienced serious adverse events or clinically
significant (Grade ≥3) laboratory abnormalities. One patient
discontinued treatment on Day 45 due to an adverse event but
achieved SVR12.
Additional information about the GARNET study can be found on
www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA®VIEKIRAX +
EXVIERA is approved in the European Union for the treatment of
genotype 1 (GT1) chronic hepatitis C virus (HCV) infection,
including patients with compensated cirrhosis. VIEKIRAX is approved
in the European Union for the treatment of genotype 4 (GT4) chronic
HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of
paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg
with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA
tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase
inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or
without ribavirin (RBV), dosed twice daily based on patient type.
VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV,
except in genotype 1a patients with compensated cirrhosis
(Child-Pugh A), who should take it for 24 weeks with RBV.
EU IndicationVIEKIRAX is indicated in combination with
other medicinal products for the treatment of chronic hepatitis C
(CHC) in adults. EXVIERA is indicated in combination with other
medicinal products for the treatment of CHC in adults.
Important EU Safety Information
Contraindications:VIEKIRAX + EXVIERA are contraindicated
in patients with severe hepatic impairment (Child-Pugh C). Patients
taking ethinyl estradiol-containing medicinal products must
discontinue them and switch to an alternative method of
contraception prior to initiating VIEKIRAX + EXVIERA. Do not give
VIEKIRAX with certain drugs that are sensitive CYP3A substrates or
strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with
strong or moderate enzyme inducers. Do not give EXVIERA with
certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:VIEKIRAX and
EXVIERA are not recommended as monotherapy and should be used in
combination with other medicinal products for the treatment of
hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients
with CirrhosisVIEKIRAX and EXVIERA are not recommended in patients
with moderate hepatic impairment (Child-Pugh B). Patients with
cirrhosis should be monitored for signs and symptoms of hepatic
decompensation, including hepatic laboratory testing at baseline
and during treatment.
ALT elevationsTransient elevations of ALT to >5x ULN without
concomitant elevations of bilirubin occurred in clinical trials
with VIEKIRAX + EXVIERA and were more frequent in a subgroup who
were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirinExtreme caution must
be taken to avoid pregnancy in female patients and female partners
of male patients when VIEKIRAX with or without EXVIERA is taken in
combination with ribavirin, see section 4.6 and refer to the
Summary of Product Characteristics for ribavirin for additional
information.
Use with concomitant medicinal productsUse caution when
administering VIEKIRAX with fluticasone or other glucocorticoids
that are metabolized by CYP3A4. A reduction in colchicine dosage or
interruption in colchicine is recommended in patients with normal
renal or hepatic function. VIEKIRAX with or without EXVIERA is
expected to increase exposure of statins so certain statins need to
be discontinued or dosages reduced. Low dose ritonavir, which is
part of VIEKIRAX, may select for PI resistance in HIV co-infected
patients without ongoing antiretroviral therapy. HIV co-infected
patients without suppressive antiretroviral therapy should not be
treated with VIEKIRAX.
Adverse ReactionsMost common (>20 percent) adverse
reactions for VIEKIRAX + EXVIERA with RBV were fatigue and
nausea.
Full summary of product characteristics is available
at www.ema.europa.eu
Globally, prescribing information varies; refer to the
individual country product label for
complete information.
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. Paritaprevir
and ABT-493 are protease inhibitors identified through the
collaboration. Under the agreement, AbbVie is responsible for all
development and commercialization activities for the
collaboration’s lead compound, paritaprevir, as well as ABT-493,
the collaboration’s second protease inhibitor. Enanta is eligible
to receive annually tiered, double-digit royalties per product on
AbbVie’s worldwide net sales allocable to the collaboration’s
protease inhibitor products and is eligible to receive up to $80
million in commercial regulatory approval milestones for
ABT-493.
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 developed direct-acting-antiviral (DAA) inhibitors
designed for use against 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 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. In addition, Enanta has early
lead candidates for HBV and RSV in preclinical testing. Please
visit www.enanta.com for more information on Enanta’s programs and
pipeline.
Forward-Looking StatementsThis press release contains
forward-looking statements, including statements with respect to
the prospects for eight-week treatment with VIEKIRAX + EXVIERA
without ribavirin in treatment-naïve patients with GT1b chronic HCV
infection without cirrhosis. 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 on paritaprevir that is marketing VIEKIRAX + EXVIERA)
to commercialize the regimen; the development, regulatory and
marketing efforts of others with respect to competitive HCV
treatment regimens; regulatory and reimbursement actions affecting
VIEKIRAX + EXVIERA, 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 Welzel, T. et al. GARNET: High SVR Rates Following Eight-Week
Treatment with Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir for
Patients with HCV Genotype 1b Infection. Presented at the European
Association for the Study of the Liver Special Conference: New
Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure,
Paris, France on September 23-24, 2016.
2 Gower E. et al. Global epidemiology and genotype distribution
of the hepatitis C virus infection. Journal of Hepatology Update:
Hepatitis C, 2014; 61: S45-S57
3 O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS,
Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and
Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1.
Philadelphia, PA: Saunders Elsevier. 2010:1313-1335
4 Hatzakis A. et al. The state of hepatitis B and C in Europe:
report from the hepatitis B and C summit conference. Journal of
Viral Hepatitis,
5 World Health Organization. Draft global health sector
strategies: Viral hepatitis, 2016–2021. A69/32, 22 April 2016
6 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin
Microbiol Infect. 2011; 17(2):107-15
7 Messina, et al. Global distribution and prevalence of
hepatitis C virus genotypes. Hepatology 2015; 61: 77-87
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version on businesswire.com: http://www.businesswire.com/news/home/20160923005270/en/
Investor Contact:Enanta Pharmaceuticals, Inc.Carol
Miceli, 617-607-0710cmiceli@enanta.comorMedia
ContactMacDougall Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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