Enanta Pharmaceuticals Announces the Initiation of Phase 2b Clinical Trial with Regimen Containing HCV Protease Inhibitor ABT...
September 10 2014 - 10:22AM
Business Wire
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 AbbVie, Enanta’s development partner for protease
inhibitors for hepatitis C virus (HCV), has initiated a phase 2b
clinical study with ABT-493, Enanta’s next-generation protease
inhibitor. ABT-493 is the second clinical-stage protease inhibitor
candidate developed within the Enanta-AbbVie collaboration.
The phase 2b study being conducted by AbbVie will evaluate the
safety and efficacy of ABT-493 co-administered with ABT-530,
AbbVie’s next generation NS5A inhibitor, in HCV patients. AbbVie
has informed Enanta that results from this trial are expected in
2015 and AbbVie plans to start phase 3 development of the
combination next year. Additional details regarding this study will
be available when they are posted by AbbVie at
www.clinicaltrials.gov.
“The goal of our collaboration’s next-generation protease
inhibitor program is a pan-genotypic, ribavirin-free, once-daily
dosing regimen for HCV patients,” stated Jay R. Luly, Ph.D.,
President and CEO.
About ABT-493
ABT-493 is a next-generation HCV NS3/4A protease inhibitor
identified within the Enanta-AbbVie collaboration. Designed to
enable once-daily dosing without ritonavir, ABT-493 is expected to
be co-formulated with AbbVie’s next-generation NS5A inhibitor,
ABT-530. Protease plays an essential role in the viral life cycle
of the hepatitis C virus (HCV). Inhibition of the protease prevents
non-structural (NS) proteins from forming and thereby prevents
replication and survival of the HCV virus.
Protease Inhibitor Collaboration with AbbVie
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 and
ABT-493 are protease inhibitors identified through the
collaboration. Under the agreement, AbbVie is responsible for all
development and commercialization activities for ABT-450, the
collaboration’s lead compound that has been submitted for approval
in the United States and the European Union as part of a multi-drug
regimen. Enanta received $57 million in connection with signing the
collaboration agreement and is eligible to receive payments for
regulatory and reimbursement approval milestones, as well as
tiered, double-digit royalties worldwide on any revenue allocable
to the collaboration’s protease inhibitors. Also, for ABT-493 or
any other additional collaborative HCV protease inhibitor product
candidate developed under the agreement, Enanta holds an option to
modify the U.S. portion of its rights to receive milestone payments
and worldwide royalties. If it exercises 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
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 (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 Statement Disclaimer
This press release contains forward-looking statements,
including statements with respect to the potential of AbbVie’s HCV
treatment regimen containing ABT-493 and Enanta’s expectations for
the timing of future clinical development of such regimen.
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 ABT-493) to
obtain regulatory approvals and commercialize treatment regimens
containing ABT-493, the development, regulatory and marketing
efforts of others with respect to competitive HCV treatment
regimens, regulatory and reimbursement actions affecting any
ABT-493-containing regimen, any competitive regimen, or both, and
the level of market acceptance and the pricing and rate of
reimbursement for any ABT-493-containing regimen. 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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