Thursday, August 7, 2014

Hepatitis C - Enanta Advances Into Combination Studies with Alisporivir (DEB025)

Enanta Pharmaceuticals’ HCV NS5A Inhibitor EDP-239 Advances into Combination Studies with Alisporivir (DEB025)

WATERTOWN, Mass., Aug 07, 2014 (BUSINESS WIRE) -- Enanta Pharmaceuticals, Inc. /quotes/zigman/14557530/delayed/quotes/nls/enta ENTA +0.24% 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 .
“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.


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