- Sustained virologic response 12 weeks
post-treatment (SVR12) of 91 percent was achieved in Japanese
patients with genotype 1b (GT1b) hepatitis C virus (HCV) infection
and with compensated cirrhosis1
- AbbVie’s treatment for Japanese
patients with GT1b HCV infection consists of a 12-week, two
direct-acting antiviral, fixed-dosed combination of
paritaprevir/ritonavir/ombitasvir, dosed once daily
- Regimen contains Enanta’s lead protease
inhibitor, paritaprevir
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases,
announced today that new data from AbbVie’s phase 3 GIFT-I study,
its investigational, all-oral, interferon (IFN)- and ribavirin
(RBV)-free, two direct-acting antiviral treatment with
ombitasvir/paritaprevir/ritonavir, was presented at the Annual
Meeting of the Japan Society of Hepatology in Kumamoto, Japan.1
GIFT-I evaluated genotype 1b (GT1b) chronic hepatitis C virus
(HCV) infected Japanese patients, with and without cirrhosis, who
were either treatment-naïve or Interferon (with or without RBV)
treatment-experienced.1 The primary endpoint was achieved,
demonstrating 95 percent (n=106/112) SVR12 in a sub-group of
treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese
patients who were eligible for therapy with IFN and had a high
viral load.1 In study results related to the secondary endpoint,
GT1b HCV patients with compensated cirrhosis achieved 91 percent
(n=38/42) SVR12.
In an additional intent-to-treat (ITT) analysis, SVR12 was
achieved in 98 percent (n=104/106) of the GT1b HCV infected
patients without cirrhosis (Arm B) who were randomized to initially
receive double-blind placebo for 12 weeks, followed by open-label
treatment with ombitasvir/paritaprevir/ritonavir.1 The ITT
population included every patient that was randomized to placebo
and received at least one dose of active, open-label study
drug.
Across all study arms, three patients (n=3/363) discontinued
treatment due to adverse events.1 The most commonly reported
adverse events (>5 percent in any arm) were nasopharyngitis,
headache, peripheral edema, nausea, pyrexia and decreased platelet
count.1
In Japan, approximately 1.5 to 2 million people are living with
HCV.2 60 to 70 percent of Japanese HCV patients are infected with
Genotype 1, and of those, about 95 percent are infected with the
GT1b sub-type.3 AbbVie studied its two direct-acting antiviral
treatment regimen without RBV in Japan due to patient and viral
characteristics specific to the Japanese population, including high
prevalence of GT1b.
Paritaprevir is Enanta’s lead protease inhibitor identified
within the ongoing Enanta-AbbVie collaboration and is one of the
two direct-acting antivirals (2-DAA) in AbbVie’s treatment regimen
currently under priority review by the Japanese Ministry of Health,
Labour and Welfare. AbbVie has previously announced that it expects
regulatory approval of the 2-DAA treatment regimen in Japan in the
second half of 2015. Upon commercialization regulatory approval in
Japan, Enanta will be entitled to a $30 million milestone payment
from AbbVie. In addition, Enanta will be eligible to receive
annually tiered royalties, ranging from the low double digits up to
twenty percent, on AbbVie’s aggregate net sales of all
paritaprevir-containing regimens, including 45% of AbbVie’s
worldwide net sales of any 2-DAA regimen.
Paritaprevir is included in AbbVie’s HCV treatment regimens
approved in the U.S. in late 2014 and in the E.U. in early
2015.
About GIFT-I StudyGIFT-I comprises 363 patients in two
sub-studies. In sub-study 1, 321 genotype 1b (GT1b) patients
without cirrhosis, both treatment-naïve and interferon (IFN) [with
or without ribavirin (RBV)] treatment-experienced, were randomized
to receive either ombitasvir/paritaprevir/ritonavir (Arm A)
[OBV/PTV/r] or placebo (Arm B) [2:1 randomization ratio, stratified
by treatment history, past response, viral load and IFN
eligibility]. Patients initially randomized to placebo (Arm B) then
received OBV/PTV/r for an additional 12 weeks of open-label
treatment. Sustained virologic response was assessed 12 weeks
post-treatment (SVR12) as a primary efficacy endpoint in a
sub-group of previously untreated, non-cirrhotic GT1b patients who
were eligible for therapy with IFN and had a high viral load,
defined as an HCV RNA level ≥ 100,000 IU/mL and received at least
one dose of the double-blind, active study drug.1
In sub-study 2, 42 GT1b treatment-naïve and IFN (with our
without RBV) treatment-experienced patients with compensated
cirrhosis received open-label treatment for 12 weeks (Arm C) with
SVR12 and assessed as a secondary efficacy endpoint.1
One patient from each arm (n=3/363) experienced on-treatment
virologic failure [Arm A, 0.5% (n=1/215); Arm B, 0.9% (n=1/106);
Arm C, 2.4% (n=1/42)].1 Across all arms, eight patients (n=8/354)
experienced post-treatment relapse [Arm A, 2.4% (n=5/209); Arm B,
1.0% (n=1/105); Arm C, 5.0% (n=2/40)].1
Protease Inhibitor Collaboration with AbbVieIn 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. AbbVie is Abbott’s successor under the agreement and
is responsible for all development and commercialization activities
for paritaprevir, as well as ABT-493, the collaboration’s
next-generation protease inhibitor.
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 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,
and nucleotide polymerase – as well as a host-targeted antiviral
(HTA) inhibitor class targeted against cyclophilin. In addition,
Enanta has a preclinical program in non-alcoholic steatohepatitis,
or NASH, which is a condition that results in liver inflammation
and damage caused by a buildup of fat in the liver.
Forward Looking Statements DisclaimerThis press release
contains forward-looking statements, including with respect to the
prospects for AbbVie’s paritaprevir-containing, 2-DAA regimen under
development for HCV in Japan. . 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 the efforts of
AbbVie (our collaborator on paritaprevir) regarding regulatory
approval and commercialization in Japan for AbbVie’s treatment
regimens containing paritaprevir and for competitive treatment
regimens; the level of market acceptance and the pricing and rate
of reimbursement for the AbbVie’s regimen in Japan; the impact of
competitive products on the use and sales of the AbbVie regimen in
Japan; 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, 2014 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 Chayama K, et al. Ombitasvir/paritaprevir/ritonavir for
Treatment of HCV Genotype 1b in Japanese Patients With or Without
Cirrhosis: Results from GIFT-I. Presented at the Annual Meeting of
the Japan Society of Hepatology. May 21-23; Kumamoto, Japan
2 Kohnodai Hospital. National Center for Global Health and
Medicine [cited 20 February 2013]. Available from:
http://www.ncgm.go.jp/center/forpatient_hcv.html
3 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10:
553-562.
http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html
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version on businesswire.com: http://www.businesswire.com/news/home/20150526006288/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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