- New data demonstrated high SVR12 rates
across compensated cirrhotic patients with genotype 1, 2, 4, 5 or 6
chronic hepatitis C virus infection with 12 weeks of
treatment1
- No patients discontinued treatment due
to adverse events in the Phase 3 EXPEDITION-1 study1
- Study results add to body of data for
G/P in patients with compensated cirrhosis across all
genotypes
- Glecaprevir is Enanta’s second protease
inhibitor being developed through its collaboration with AbbVie and
is one of the two new direct-acting antivirals (DAAs) in G/P
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 99 percent (n=145/146) of chronic hepatitis C virus
(HCV) infected patients with genotype 1, 2, 4, 5 or 6 and
compensated cirrhosis (Child-Pugh A) achieved sustained virologic
response at 12 weeks post-treatment (SVR12) with AbbVie’s
investigational, pan-genotypic, ribavirin-free regimen of
glecaprevir/pibrentasvir (G/P). This high SVR12 rate was seen
following 12 weeks of G/P treatment without ribavirin. Patients
with specific virus strains associated with resistance or with a
high quantity of the virus in their bloodstream before treatment
initiation were not excluded from the study. These new data, from
the Phase 3 EXPEDITION-1 study, will be featured as an oral
presentation today at The International Liver Congress™ (ILC) 2017
in Amsterdam, The Netherlands.
In the EXPEDITION-1 study, the majority of adverse events (AEs)
were mild, and no patients discontinued treatment due to an AE. The
most common (≥10 percent) AEs were fatigue and headache.
Approximately 130 to 150 million people worldwide are living
with chronic HCV, for whom the risk of cirrhosis of the liver is
between 15-30% within 20 years.2 Treatment guidelines around the
world recommend that all patients with cirrhosis should be
considered for treatment, yet the treatment of specific patients
with HCV and compensated cirrhosis is still challenging.3,4
AbbVie is presenting additional data at ILC in patients with
specific treatment challenges, including in those with chronic
kidney disease (SAT-273), HIV-1 co-infection (LBP-522), post liver
transplant, and post renal transplant (LBO-03), as well as in
patients who did not achieve SVR12 with previous direct-acting
antiviral treatment (PS-156). Additional information on the
clinical trials for G/P is available at
http://www.clinicaltrials.gov.
Authorization applications for G/P are currently under review by
regulatory authorities around the world. G/P has been granted
accelerated assessment by the European Medicines Agency, and
priority review designations by the U.S. Food and Drug
Administration and Japanese Ministry of Health, Labour and Welfare.
G/P is an investigational regimen and its safety and efficacy have
not been established.
About the EXPEDITION-1 StudyEXPEDITION-1 is a single arm,
multicenter, open-label study evaluating the efficacy and safety of
12 weeks of G/P in adults with GT1, 2, 4, 5 or 6 chronic HCV
infection and compensated cirrhosis (Child-Pugh A). The study
enrolled 146 patients, including those new to treatment or those
who had prior treatment experience with IFN-based treatments
(IFN/pegIFN ± RBV, or sofosbuvir + RBV ± pegIFN). The primary
endpoint was the percentage of patients achieving SVR12. SVR12 was
achieved by 145/146 (99 percent) patients, with one GT1a-infected
patient experiencing relapse.
No patients experienced ALT elevations equal to or above Grade
3. Of the 11 patients (7.5 percent) who experienced serious AEs,
none were considered treatment-related.
About G/PG/P is an investigational, pan-genotypic regimen
that is being evaluated by AbbVie as a potential cure in 8 weeks
for HCV patients without cirrhosis and who are new to treatment
with direct-acting antivirals (DAAs)*, who make up the majority of
HCV patients. AbbVie is also studying G/P in patients with specific
treatment challenges, such as patients with genotype 3 HCV,
patients who were not cured with previous DAA treatment and those
with chronic kidney disease, including patients on dialysis.
G/P is an investigational, once-daily regimen that combines two
distinct antiviral agents in a fixed-dose combination of
glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir
(120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral
tablets.
Additional information on AbbVie’s clinical trials for G/P is
available at www.clinicaltrials.gov.
*Patients who are treatment-naive or had prior treatment
experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV
+/- pegIFN).
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 efforts are currently focused on
the following disease targets: non-alcoholic steatohepatitis
(NASH)/ primary biliary cholangitis (PBC), respiratory syncytial
virus (RSV) and hepatitis B virus (HBV).
Enanta has discovered novel protease inhibitors for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir,
part of AbbVie’s currently marketed HCV regimens, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie
is developing as part of its investigational, pan-genotypic HCV
regimen of glecaprevir/pibrentasvir (G/P) now in registration in
the U.S., the E.U. and Japan. Royalties and any further milestone
payments from this collaboration will provide additional funding
for Enanta’s earlier development programs, including its Phase 1
FXR agonist program for NASH/PBC, and its preclinical programs for
HBV and RSV. 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 AbbVie’s G/P regimen for HCV. 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 glecaprevir) to
obtain regulatory approvals of its glecaprevir/pibrentasvir (G/P)
combination and commercialize it successfully; the regulatory and
marketing efforts of others with respect to competitive treatment
regimens for HCV; regulatory and reimbursement actions affecting
G/P, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; 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, 2016 and 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 Forns, X et al. EXPEDITION-1: Efficacy and Safety of
Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus
Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis.
Presented at The International Liver Congress™ (ILC) in Amsterdam,
The Netherlands, April 19-23, 2017.
2 Hepatitis C. World Health Organization. World Health
Organization, July 2016. Web.
http://www.who.int/mediacentre/factsheets/fs164/en/
3 EASL Recommendations on Treatment of
Hepatitis C 2016. J Hepatol (2016),
http://dx.doi.org/10.1016/j.jhep.2016.09.001.
4 Spach D, Scott J. Treatment of Hepatitis C in
Patients with Cirrhosis. Hepatitis C Online.
http://cdn.hepatitisc.uw.edu/pdf/special-populations-situations/treatment-cirrhosis/core-concept/all
Published 2015. Accessed April 3, 2017.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170420005690/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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