Enanta Pharmaceuticals Announces Preliminary Data from AbbVie’s Phase 3b RUBY-I Study in Chronic Hepatitis C Patients with ...
April 25 2015 - 10:04AM
Business Wire
- In preliminary data from RUBY-I,
patients receiving VIEKIRAX + EXVIERA with or without ribavirin who
reached post-treatment week four (n=10 of 20 enrolled) achieved 100
percent sustained virologic response at four weeks post-treatment
(SVR4)1
- Treatment regimen evaluating
VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA®
(dasabuvir tablets) with or without ribavirin (RBV) 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 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 of care 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.
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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