New GT-1b Data from ABT-450 Containing Regimen Being Presented at The Liver Meeting
November 03 2013 - 9:00AM
Business Wire
SVR12 Rates of 95% in HCV Treatment Naïve
Patients and 90% in Prior Null Responders Reported in PEARL-I
Study
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA) a research and
development-focused biotechnology company dedicated to creating
small molecule drugs in the infectious disease field, today
announced that additional data from AbbVie’s M13-393 study,
referred to as PEARL-I, will be presented in an oral presentation
at 5:15 p.m. ET today at The Liver Meeting, the 64th Annual Meeting
of the American Association for the Study of Liver Diseases (AASLD)
in Washington, D.C.
In PEARL-I, SVR12 rates of 95% (40/42) in hepatitis C (HCV)
GT-1b treatment-naïve patients and 90% (36/40) among prior null
responders will be presented in this intent-to-treat analysis. Two
patients in the treatment-naive arm did not achieve SVR12 due to
loss to follow up. In the null responder arm, one patient
experienced breakthrough and three patients relapsed.
PEARL-I is a phase-2b, interferon-free, 320 patient study being
conducted by AbbVie to evaluate the once-daily, two-DAA regimen
consisting of ABT-450/r (protease inhibitor plus ritonavir) +
ABT-267 (AbbVie’s NS5A inhibitor) in HCV treatment-naïve patients
and treatment-experience patients. GT-1b treatment arms are
ribavirin-free and also include cirrhotic patients while GT-4 arms
explore treatment with and without ribavirin.
“We are very encouraged by the strong SVR12 rates from this
simplified 2-DAA, once-daily regimen that includes our lead HCV
protease inhibitor, ABT-450,” commented Jay R. Luly, Ph.D.,
President and Chief Executive Officer. “We look forward to data
from Phase 3 studies of three-DAA regimens containing ABT-450 being
reported in the coming months.”
Protease Inhibitor Collaboration with AbbVie (formerly the
research-based pharmaceutical business of Abbott
Laboratories)
In 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. ABT-450 is a
protease inhibitor identified as a lead compound through the
collaboration. Under the agreement, AbbVie is responsible for all
development and commercialization activities for ABT-450. Enanta
received $57 million in connection with signing the collaboration
agreement, has received $55 million in subsequent clinical
milestone payments, and is eligible to receive an additional $195
million in payments for regulatory milestones, as well as
double-digit royalties worldwide on any revenue allocable to the
collaboration’s protease inhibitors. Also, for any additional
collaborative HCV protease inhibitor product candidate developed
under the agreement, Enanta holds an option to modify the U.S.
portion of it rights to receive milestone payments and worldwide
royalties. With this option, Enanta can fund 40 percent of
U.S. development costs and U.S. commercialization
efforts (sales and promotion costs) for the additional
protease inhibitor in exchange for 40 percent of any U.S.
profits ultimately achieved after regulatory approval instead
of receiving payments for U.S. commercial regulatory
approval milestones and royalties on U.S. sales of that protease
inhibitor.
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 in the infectious disease field. Enanta is discovering and
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 (partnered with Novartis) and nucleotide polymerase –
as well as a host-targeted antiviral (HTA) inhibitor class targeted
against cyclophilin. Additionally, Enanta has created a new class
of antibiotics, called Bicyclolides, for the treatment of
multi-drug resistant bacteria, with a focus on developing an
intravenous and oral treatment for hospital and community MRSA
(methicillin-resistant Staphylococcus aureus) infections.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including with respect to clinical data, plans for announcing
additional data, and the planned clinical development of ABT-450.
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 final results of ongoing clinical trials, the development
and marketing efforts of AbbVie (our collaborator on ABT-450),
regulatory actions affecting clinical development of ABT-450 and
clinical development of competitive product candidates. 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.
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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