Enanta Pharmaceuticals’ HCV NS5A Inhibitor EDP-239 Advances into Combination Studies with Alisporivir (DEB025)
August 07 2014 - 8:30AM
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 Novartis has advanced EDP-239, Enanta’s NS5A
inhibitor for hepatitis C virus (HCV), into drug combination
studies with alisporivir (DEB025), a cyclophilin inhibitor being
developed by Novartis. These combination studies are part of
Enanta’s existing collaboration with Novartis for the development
of new combination therapies for the treatment of HCV using
Enanta’s NS5A inhibitors.
EDP-239 is a direct-acting anti-viral (DAA) that directly
inhibits replication of HCV. Alisporivir (DEB025) blocks HCV
replication by targeting proteins in the host cell that are
critical to replication of the hepatitis C virus (HCV). As a
host-targeting antiviral (HTA), alisporivir (DEB025) is expected to
have a high barrier to HCV resistance. It has also demonstrated in
vitro anti-HCV activity across multiple HCV genotypes. As the most
advanced oral HTA1, alisporivir (DEB025), when combined with
EDP-239, may be an attractive drug combination for the
next-generation of interferon-free HCV therapies.
The phase 1 combination study conducted by Novartis is
investigating the pharmacokinetics, safety, and tolerability of
alisporivir (DEB025) and EDP-239 when co-administered to healthy
adult subjects and is scheduled to enroll 42 healthy subjects.
For more information on the complete study design, please visit
www.clinicaltrials.gov.
“EDP-239 in combination with a cyclophilin inhibitor such as
alisporivir provides a new combination of mechanisms to explore in
the clinic,” commented Jay R. Luly, Ph.D., President and CEO. “The
advancement of EDP-239 in partnership with Novartis provides Enanta
with another opportunity to participate in additional HCV regimens
under development.”
About EDP-239
EDP-239 is Enanta’s lead NS5A inhibitor for HCV infection. NS5A
is a non-structural (NS) viral protein that is essential to viral
replication of HCV. EDP-239 has demonstrated potent activity
against major HCV genotypes when tested in the replicon assay,
which is a common in vitro test for determining potency of an
active compound in reducing HCV replication. In addition, EDP-239
has additive or synergistic antiviral activity when used in
combination with other anti-HCV therapeutics (DAA and HTA) in
reducing HCV replication. Enanta's NS5A program and intellectual
property estate in the HCV field were derived from its internal
drug discovery efforts.
NS5A Collaboration with Novartis
On February 16, 2012, Enanta entered into a license and
collaboration agreement with Novartis for the development,
manufacture and commercialization of its lead development
candidate, EDP-239, and other NS5A inhibitor compounds. Under the
terms of the agreement, Enanta received an upfront payment of $34
million and an $11 million milestone payment and is eligible to
receive up to a total of $395 million in milestone payments if
certain clinical, regulatory, and commercial milestones are met.
Enanta is also eligible to receive tiered double-digit royalties on
worldwide sales of products.
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 Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for clinical
development of EDP-239 and the prospects for milestone payments to
Enanta resulting from such development and any subsequent
regulatory approvals and commercial sales. 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
Novartis (our collaborator on EDP-239) to develop EDP-239 and
obtain regulatory approvals and commercialize treatment regimens
containing it, the development, regulatory and marketing efforts of
others with respect to competitive HCV treatment regimens, and
changes in the market for HCV therapies. 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 The Combination of Alisporivir plus an NS5A
Inhibitor Provides Additive to Synergistic Anti-Hepatitis C Virus
Activity without Detectable Cross-Resistance -
Chatterji U, et.al. Antimicrob Agents Chemother. 2014
Jun;58(6):3327-3334. Epub 2014 Mar 31.
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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