- In the CERTAIN-1 study, 99 percent
(n=105/106) of genotype 1 (GT1) chronic hepatitis C virus
(HCV)-infected Japanese patients without cirrhosis achieved SVR12
with 8 weeks of G/P treatment
- Japan has one of the highest rates of
hepatitis C infection in the industrialized world affecting
approximately 1 million people, 60 to 70 percent of those are
GT11,2,3
- G/P includes Enanta’s second protease
inhibitor, glecaprevir (ABT-493)
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 results from AbbVie’s Phase 3 CERTAIN-1 study of 8 weeks
of treatment with AbbVie’s investigational, pan-genotypic,
ribavirin (RBV)-free regimen of glecaprevir (ABT-493)/pibrentasvir
(ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic
hepatitis C virus (HCV) infection without cirrhosis. Top-line
results from the study demonstrated 99 percent (n=105/106) of
patients without cirrhosis, who represent the majority of HCV
patients, and without the Y93H variant, achieved sustained
virologic response at 12 weeks after treatment (SVR12). The one
patient who did not reach SVR12 in this intent to treat (ITT)
population was lost to follow-up. All 23 patients with the Y93H
variant were assigned to the G/P arm of this comparator study, and
100% achieved SVR12.
These data are the first to be released by AbbVie from
registrational studies in Japan as part of its global G/P clinical
development program, designed to investigate a faster path to
virologic cure* for all major HCV genotypes and with the goal of
addressing treatment areas of continued unmet need. The results
demonstrated from the CERTAIN-1 study are consistent with recently
announced 8-week, GT1 data from AbbVie’s global registration
studies of G/P.
Approximately 1 million people are living with hepatitis C in
Japan, with 60 to 70 percent of those infected with GT1 chronic
HCV.1,3 Patients participating in the CERTAIN-1 study were further
representative of the HCV-infected patient population in Japan,
where the prevalence of HCV infection increases with age, because a
majority of patients in the study were over 65 years of age.4
The CERTAIN-1 study compared the safety and efficacy of 8 weeks
of treatment with the investigational G/P regimen to 12 weeks of
treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), in
GT1 chronic HCV-infected patients. The primary endpoint of the
study was met, as 8 weeks of G/P was shown to be non-inferior to 12
weeks of OBV/PTV/r (100 percent SVR12; n=52).
Additionally, in sub-study 1 evaluating GT1 patients (treated
with G/P) without cirrhosis and who were new to treatment with
direct-acting antivirals (DAA), no patients discontinued treatment
due to adverse events (AEs). In patients treated with OBV/PTV/r,
there was one who discontinued treatment due to AEs. In patients
receiving the G/P regimen, the most common AEs, occurring at a rate
greater than 5 percent, were nasopharyngitis (inflammation of the
throat and nasal passages) and pruritus (itchiness).
About the CERTAIN-1 Study
The CERTAIN-1 study is a Phase 3, multicenter study evaluating
the efficacy, safety and pharmacokinetics (PK) of G/P in Japanese
adults. Sub-study 1 is a randomized, open-label and
active-controlled study in genotype 1 (GT1) chronic HCV-infected
patients without cirrhosis who are new to DAA treatment. Patients
who tested negative for the Y93H resistance associated variant
received either 8 weeks of G/P or 12 weeks of OBV/PTV/r (2:1
randomization ratio). All Y93H positive patients were assigned to
receive 8 weeks of G/P and all (n=23/23) achieved SVR12. The
primary objectives were safety and non-inferiority of G/P compared
to OBV/PTV/r.
Sub-study 2 is a non-randomized, open-label study evaluating
GT1-6 HCV patients with specific treatment challenges, including
those with compensated cirrhosis (Child-Pugh A), chronic kidney
disease (CKD) and those who were not cured with previous DAA
treatment.
AbbVie plans to present additional data at an upcoming
scientific congress.
About AbbVie’s G/P Clinical Development Program
AbbVie’s glecaprevir/pibrentasvir (G/P) clinical development
program was designed to investigate a faster path to virologic
cure* for all major HCV genotypes (GT1-6) and with the goal of
addressing treatment areas of continued unmet need. In Japan,
AbbVie studied the G/P regimen in additional dedicated clinical
trials due to patient and viral characteristics specific to the
Japanese HCV patient population.
G/P is an investigational, pan-genotypic regimen that is being
evaluated as a potential cure in 8 weeks for HCV patients without
cirrhosis who are new to treatment with direct-acting antivirals
(DAA). Patients with these characteristics constitute 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 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.
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.
G/P is an investigational product and its safety and efficacy
have not been established in Japan.
*Patients with a sustained virologic response at 12 weeks post
treatment (SVR12) are considered cured of hepatitis C.
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 for viral infections and liver diseases. Enanta’s research
and development efforts are currently focused on three 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 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 is developing as part of an
investigational, pan-genotypic, once-daily, ribavirin-free,
fixed-dose combination with pibrentasvir (ABT-530), (G/P), AbbVie’s
second NS5A inhibitor.
Enanta has discovered EDP-305, an FXR agonist product candidate
for NASH and PBC, currently in Phase 1 clinical development, and
has identified a clinical candidate for RSV, EDP-938, now, in
preclinical development. Enanta is also developing early lead
candidates for HBV. 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 G/P
regimen in 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 National Center for Global
Health and Medicine. Hepatitis C. Assessed January 2017. Available
from: http://www.kanen.ncgm.go.jp/cont/010/c_gata.html
2 Gower, E. Global epidemiology and genotype distribution of the
hepatitis C virus infection. Journal of Hepatology 2014; 61:
S45-S57, Table 2.
3 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10:
553-562. Available from:
http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html
4 Chung H, Taisuke U, Masatoshi K. Changing Trends in Hepatitis
C Infection over the Past 50 Years in Japan. Intervirology
2010;53:39–43.
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version on businesswire.com: http://www.businesswire.com/news/home/20170109005300/en/
InvestorsEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMediaMacDougall Biomedical
CommunicationsKari Watson, 781-235-3060kwatson@macbiocom.com
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