[April 25, 2015] |
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Enanta Pharmaceuticals Announces Preliminary Data from AbbVie's Phase 3b RUBY-I Study in Chronic Hepatitis C Patients with Renal Impairment Presented at The International Liver Congress™ 2015
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
new preliminary safety and efficacy data from the first cohort of
AbbVie's ongoing, Phase 3b RUBY-I study. RUBY-I is evaluating the
regimen of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) +
EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV) in
treatment-naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C
patients with severe renal impairment (stage 4 or 5), including those on
hemodialysis. The primary endpoint of the study is the percentage of
patients achieving sustained virologic response at 12 weeks
post-treatment (SVR12). The first ten patients, or 100
percent, who have reached post-treatment week four to date (n=10 of 20
enrolled) achieved SVR4 (n=10/10).1 The RUBY-I
study was presented as a late-breaker today at The International Liver
Congress™ (ILC) 2015, the 50th annual meeting of the European
Association for the Study of the Liver (EASL) in Vienna, Austria.
"We are encouraged by this promising data in this difficult-to-treat
patient population," stated Jay R. Luly, Ph.D., President and Chief
Executive officer. "We look forward to the final data from this and
other studies that AbbVie is conducting in special populations."
RUBY-I data showed no virologic failures to date.1
Preliminary safety analyses reported that patients experienced mainly
mild or moderate adverse events when receiving VIEKIRAX + EXVIERA with
or without RBV, most commonly (> 20 percent) anemia, fatigue, diarrhea,
nausea, dizziness and headache.1 To date, eight of 13 GT1a
patients had a RBV dose interruption.1
Paritaprevir, Enanta's lead protease inhibitor, is one of the three
direct-acting antivirals (DAAs) included in AbbVie's HCV treatment
regimens approved in the U.S. for genotype 1 chronic hepatitis C virus
as VIKIERA PAK®, in the E.U. as VIEKIRAX® + EXVIERA®, and in Canada as
HOLKIRA PAK®. AbbVie is responsible for all development and
commercialization activities for regimens that contain paritaprevir.
Additional Phase 3b studies from AbbVie presented at ILC 2015 included
MALACHITE-I and MALACHITE-II data, and TOPAZ-I and TOPAZ-II study
design. The MALACHITE studies evaluate adult patients with GT1 chronic
HCV infection without cirrhosis receiving VIEKIRAX + EXVIERA with or
without RBV compared to treatment with telaprevir with
pegylated-interferon and RBV, which remains the standard ofcare in many
regions of the world.2,3 The TOPAZ studies will evaluate the
effect of SVR12 on long-term outcomes five years following
treatment with VIEKIRAX + EXVIERA with or without RBV in adults with GT1
chronic HCV infection.4
About RUBY-I Study
RUBY-I is an ongoing multi-center, open-label, Phase 3b study with two
cohorts to evaluate the safety and efficacy of 12 or 24 weeks of
treatment with VIEKIRAX® + EXVIERA® with or without ribavirin, based on
sub-genotype in treatment-naïve, adult patients with genotype 1 (GT1)
chronic hepatitis C virus infection who have severe renal impairment
(pre-dialysis; stage 4 chronic kidney disease) or end-stage renal
disease (on hemodialysis; stage 5 chronic kidney disease) with or
without compensated cirrhosis.1 Cohort 1 consists of 20
patients without cirrhosis and cohort 2 will evaluate approximately 20
patients with or without compensated cirrhosis. Ribavirin was started at
200mg once daily for all GT1a-infected patients and dosed four hours
prior to the start of GT1a patients on hemodialysis. Additional study
results, including cohort 2, will be disclosed at future scientific
congresses.
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 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. Enanta's lead
protease inhibitor, paritaprevir, is part of AbbVie's recently approved
HCV treatment regimens. 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 Statement Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for clinical study results with
treatment regimens containing paritaprevir for HCV. 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) to develop and
obtain additional regulatory approvals for treatment regimens containing
paritaprevir; the development, regulatory and marketing efforts of
others with respect to competitive HCV treatment regimens; regulatory
and reimbursement actions affecting any paritaprevir-containing
regimens, any competitive regimens, 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, 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 Pockros P, et al. Safety Of
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir For Treating HCV GT1
Infection In Patients With Severe Renal Impairment Or End-stage Renal
Disease: The RUBY-I Study. Presented at the 50th International Liver
Congress (ILC); April 22-26; Vienna, Austria
2 Conway B, et al. MALACHITE-I: Phase 3b Trial Of
Ombitasvir/Paritaprevir/R And Dasabuvir +/-Ribavirin Or Telaprevir +
Peginterferon/Ribavirin In Treatment-naïve Adults With HCV Genotype 1.
Abstract presented at the 50th International Liver Congress (ILC); April
22-26; Vienna, Austria
3 Dore G, et al. MALACHITE-II: Phase 3b Trial Of
Ombitasvir/Paritaprevir/R And Dasabuvir + Ribavirin Or Telaprevir +
Peginterferon/Ribavirin In Peginterferon/Ribavirin Treatment-experienced
Adults With HCV Genotype 1. Abstract presented at the 50th International
Liver Congress (ILC); April 22-26; Vienna, Austria
4 Dumas E, et al. Phase 3b Studies To Assess Long-term
Clinical Outcomes In HCV GT1-infected Patients Treated With
Ombitasvir/Paritaprevir/Ritonavir And Dasabuvir With Or Without
Ribavirin. Abstract presented at the 50th International Liver Congress
(ILC); April 22-26; Vienna, Austria.
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