If approved, G/P will provide an eight week once-daily,
ribavirin-free treatment option for HCV patients without cirrhosis
across all major genotypes
AbbVie’s investigational regimen was granted Breakthrough Therapy
Designation by the FDA for genotype 1 (GT1) patients who failed
previous therapy with direct-acting antivirals (DAAs)
G/P includes Enanta’s second protease inhibitor, glecaprevir
AbbVie is on track to submit Marketing Authorization Application
for G/P in the European Union in early 2017
WATERTOWN, Mass.--(BUSINESS WIRE)--Dec. 19, 2016--
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 AbbVie has submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) for its investigational, pan-genotypic,
fixed-dose combination of glecaprevir (ABT-493) and pibrentasvir
(ABT-530) (G/P), being evaluated for the treatment of chronic HCV. In
Phase 3 clinical studies, eight weeks of therapy with G/P demonstrated
high sustained virologic response (SVR) rates across all major genotypes
(GT1-6) in patients without cirrhosis and who are new to treatment,
which represent the majority of HCV patients. In patients with
compensated cirrhosis, high SVR rates were achieved after 12 weeks of
therapy. High SVR rates were also achieved in patients with limited
treatment options, such as those with severe chronic kidney disease
(CKD). In historically difficult to treat populations, including those
not cured* by prior direct-acting antiviral (DAA) treatment regimens,
high rates of SVR were achieved with durations as short as 12 weeks.
“We are pleased with the data that AbbVie has submitted with this NDA,
and that once-daily G/P has the potential to bring an 8-week treatment
option to treatment-naïve, non-cirrhotic HCV patients across all major
genotypes,” stated Jay R. Luly, Ph.D.
The NDA is supported by data from eight registrational studies in
AbbVie's G/P clinical development program, which evaluated more than
2,300 patients in 27 countries across major HCV genotypes and special
populations. Patient populations studied included all major genotypes,
new and experienced to treatment, those with and without cirrhosis and
patients with specific treatment challenges, including those with severe
CKD, and those who have failed a DAA-containing regimen.
AbbVie previously announced registrational data that show with eight
weeks of treatment, 97.5 percent (n=693/711) of chronic HCV patients
across all major genotypes (GT1-6) without cirrhosis and new to
treatment achieved SVR12. Additional data submitted show that
with 12 weeks of treatment, 98 percent (n=102/104) of severe CKD
patients achieved SVR12 in a primary intent-to-treat (ITT)
analysis. In a modified intent-to-treat (mITT) analysis of severe CKD
patients, 100 percent (n=102/102) of patients achieved SVR12.
The mITT analysis excludes patients who did not achieve SVR for reasons
other than virologic failure. The most commonly reported adverse events
(AEs) for severe CKD patients were pruritus, fatigue and nausea. The
most commonly reported AEs for GT1-6 patients without cirrhosis and new
to treatment were headache and fatigue. These data were presented at The
American Association for the Study of Liver Diseases (AASLD) annual
meeting in November 2016. Data for other registrational studies will be
shared at future meetings.
On September 30, 2016, AbbVie announced that the FDA granted
Breakthrough Therapy Designation (BTD) for G/P for the treatment of
patients with HCV who failed previous therapy with DAAs in GT1,
including therapy with an NS5A inhibitor and/or protease inhibitor. The
BTD is supported by positive results seen in AbbVie’s Phase 2 MAGELLAN-1
clinical study. According to the FDA, BTD is intended to expedite the
development and review of therapies for serious or life threatening
AbbVie has announced it is on track to submit a marketing authorization
application for G/P in the European Union in early 2017.
About AbbVie’s Clinical Development of G/P for HCV
G/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, who make up the majority of HCV
patients. AbbVie is also studying G/P in patients with specific
treatment challenges, such as genotype 3, patients who were not cured
with previous DAA treatment and those with CKD, including patients on
G/P is a 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.
Glecaprevir is Enanta’s second protease inhibitor being developed
through its collaboration with AbbVie and is one of the two new
direct-acting antivirals in G/P.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.
*Patients who achieve a sustained virologic response at 12
weeks post treatment (SVR12) are considered
cured of HCV.
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 for viral
infections and liver diseases. Enanta’s research and development efforts
are currently focused on four disease targets: Hepatitis C Virus (HCV),
Non-alcoholic Steatohepatitis (NASH), Respiratory Syncytial Virus (RSV)
and Hepatitis B Virus (HBV).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir, which
is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie has
developed in Phase 3 studies as part of an investigational,
pan-genotypic, once-daily, ribavirin-free, fixed-dose combination (G/P)
with pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor. In addition
to the recent NDA filing with the FDA, AbbVie has announced it is on
track to submit a marketing authorization application for G/P in the
European Union in early 2017.
Enanta has also discovered EDP-305, an FXR agonist product candidate for
NASH, currently in Phase 1 clinical development, as well as a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is also in Phase 1 clinical development. In addition, Enanta
has early lead candidates for HBV and RSV in preclinical development.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s investigational
G/P treatment 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 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.
1U.S. Food and Drug Administration. Fact Sheet: Breakthrough
Accessed November 23, 2016.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161219005598/en/
Source: Enanta Pharmaceuticals, Inc.
Enanta Pharmaceuticals, Inc.
MacDougall Biomedical Communications