Enanta Announces that AbbVie’s Investigational, Pan-Genotypic Regimen of ABT-493 & ABT-530 Shows High SVR Rates in Genotype...
April 15 2016 - 1:15AM
Business Wire
- 95 percent of patients achieved SVR12
with 12 weeks of ABT-493 and ABT-530 with and without RBV in GT1
chronic HCV infected patients without cirrhosis who failed previous
therapy with DAAs in a modified intent-to-treat analysis
- 91 percent achieved SVR12 with RBV in
the primary intent-to-treat analysis; 86 percent achieved SVR12
without RBV
- ABT-493 is Enanta’s second protease
inhibitor being developed in combination with ABT-530, AbbVie’s
NS5A inhibitor
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 in AbbVie’s MAGELLAN-1 study of genotype 1 (GT1)
chronic hepatitis C virus (HCV) infected patients who failed
previous therapy with direct-acting antivirals (DAAs), 91 percent
(n=20/22) achieved sustained virologic response at 12 weeks
post-treatment (SVR12) after 12 weeks of treatment with ABT-493 and
ABT-530 with ribavirin (RBV) in the primary intent-to-treat
analysis. Additionally, 86 percent (n=19/22) of GT1 patients who
received ABT-493 and ABT-530 without RBV, achieved SVR12.1 In a
modified intent-to-treat analysis of these patients, excluding
those who did not achieve SVR for reasons other than virologic
failure, 95 percent of patients who received the regimen, with or
without RBV (n=20/21, n=19/20; respectively) achieved SVR12.
The results were evaluated in the ongoing MAGELLAN-1 study of
AbbVie’s once-daily, investigational, pan-genotypic regimen of
co-formulated ABT-493 (300mg) and ABT-530 (120mg) for the
retreatment of non-cirrhotic patients with GT1 chronic HCV who have
failed previous therapy with DAAs. These data will be presented
today at The International Liver Congress™ (ILC) 2016 in Barcelona,
Spain.
ABT-493 is Enanta’s second protease inhibitor being developed
through its collaboration with AbbVie and is one of the two new
direct-acting antivirals in the combination treatment being
investigated in the ongoing MAGELLAN-1 study.
“With limited treatment options for this difficult-to-treat
patient population, these high SVR rates are very encouraging and
show potential in treating patients who have failed DAA therapy
previously,” stated Jay R. Luly, Ph.D., President and Chief
Executive Officer.
No patients discontinued treatment due to adverse events, and
two patients experienced virologic failure, one from each arm.1 The
most common adverse events (≥10 percent of patients overall) were
headache (30 percent), fatigue (27 percent) and nausea (20
percent).1
About MAGELLEN-11MAGELLAN-1 is an ongoing Phase 2,
randomized, open-label multicenter study to evaluate the efficacy,
safety and pharmacokinetics of ABT-493 and ABT-530, with or without
RBV, in adults with genotype 1, 4, 5 or 6 chronic HCV infection who
failed a prior DAA-containing therapy.
In Part 1 of the study, 50 GT1 patients without cirrhosis who
previously failed therapy containing a protease inhibitor and/or
NS5A inhibitor, with or without a NS5B polymerase inhibitor, were
randomized to receive once-daily ABT-493 and ABT-530 at doses of
200/80mg (Arm A), 300/120mg with 800mg RBV (Arm B), or 300/120mg
without RBV (Arm C), for 12 weeks. The primary efficacy endpoint
was SVR12. Patients who failed previous treatment for reasons other
than breakthrough or relapse were excluded. Deep sequencing
(Illumina MiSeq) revealed pre-existing resistance-associated
variants (RAVs) in 41 patients (82 percent), 15 in NS3, 10 in NS5A,
and 16 with RAVs in both targets. Data presented at ILC 2016 were
based on an analysis of the intent-to-treat population.
Data from the first six patients enrolled in Arm A (once-daily
ABT-493 and ABT-530 at doses of 200/80mg) showed 100 percent
achieved SVR12. Additional patients were enrolled and received
study drug at the higher doses of the combination that will be used
in Phase 3 clinical trials, 300/120mg ABT-493/ABT-530 with or
without 800mg RBV. There were no grade 3 or 4 laboratory
abnormalities.
Part 2 of the study is underway to examine once-daily ABT-493
(300mg) and ABT-530 (120mg) without RBV in a larger group of DAA
treatment-experienced patients, including those with compensated
cirrhosis and in genotypes 4, 5 or 6.
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’s research and development is currently focused on four
disease targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV),
Non-alcoholic Steatohepatitis (NASH) and Respiratory Syncytial
Virus (RSV).
Enanta has discovered novel protease inhibitors and NS5A
inhibitors that are members of the direct-acting-antiviral (DAA)
inhibitor classes designed for use against the hepatitis C virus
(HCV). Enanta’s protease inhibitors, developed through its
collaboration with AbbVie, include paritaprevir, which is contained
in AbbVie’s marketed DAA regimens for HCV, and ABT-493, Enanta’s
second protease inhibitor, which AbbVie is developing in phase 3
studies in combination with ABT-530, AbbVie’s NS5A inhibitor.
Enanta has also discovered a cyclophilin inhibitor, EDP-494, a
novel host-targeting mechanism for HCV, which is now in phase 1
clinical development, and EDP-305, an FXR agonist, which Enanta
plans to advance into clinical development for NASH later in 2016.
Please visit www.enanta.com for more information on Enanta’s
programs and pipeline.
Forward Looking Statements DisclaimerThis press release
contains forward-looking statements, including statements with
respect to the prospects for AbbVie’s investigational HCV treatment
regimen containing ABT-493 and Enanta’s other research and
development programs. 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 ABT-493) to develop and obtain regulatory
approval of any regimens containing ABT-493 and successfully
commercialize them; the development, regulatory and marketing
efforts of others with respect to competitive HCV treatment
regimens; regulatory and reimbursement actions affecting any
ABT-493-containing HCV regimen, any competitive regimen, 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, 2015 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.
________________________________
1 Poordad, F et al. High Efficacy of ABT-493 and ABT-530 in HCV
Genotype 1 Infected Patients Who Have Failed Direct-Acting
Antiviral- Containing Regimens: The MAGELLAN-I Study. Oral
presentation #GS11 presented at The International Liver Congress™
(ILC), the Annual Meeting of the European Association for the Study
of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.
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Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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