Date: 2014-08-07
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Enanta Pharmaceuticals (USA - MA) Novartis (Switzerland)
Product: EDP-239 and DEB025 (alisporivir)
Action
mechanism: EDP-239 is a direct-acting anti-viral (DAA) that inhibits replication of HCV. EDP-239 is an NS5A inhibitor. The compound has demonstrated potent activity against major genotypes in the replicon assay. In addition, EDP-239 has additive to synergistic antiviral activity when used in combination with other anti-HCV therapeutics in the replicon assay. Alisporivir (DEB025) blocks HCV replication by targeting proteins in the host cell that are critical to replication of the hepatitis C virus (HCV).This oligopeptide is a cyclophilin (Cyp)-binding molecule with potent anti-hepatitis C virus (HCV) activity both in vitro and in vivo. It binds to CypA, a peptidyl-prolyl cis-transisomerase which is a crucial cofactor for HCV replication. It has also demonstrated in vitro anti-HCV activity across multiple HCV genotypes. Novartis in-licensed DEB025 from Debiopharm Group, an independent biopharmaceuticals company based in Switzerland, under an agreement which gives Novartis exclusive worldwide development, manufacturing and marketing rights (excluding Japan).
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: Germany
Trial
details: The study is an open-label, two part investigation of the pharmacokinetics, safety, and tolerability of alisporivir and EDP239 when wco-administered to healthy adult subjects. The purpose of Part 1 is to inform dose selection for use of alisporivir and EDP239 in combination and obtain initial safety data for co-administration of alisporivir and EDP239 to support future treatment studies in patients. The purpose of Part 2 is to inform the drug-drug interaction potential of EDP239 more broadly and possibly facilitate the interpretation of lower than expected alisporivir concentrations in Part 1, if observed. (NCT02173574)
Latest
news: * On August 7, 2014, Enanta Pharmaceuticals, a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, 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. 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. On February 2012, Enanta entered into a license and collaboration agreement with Novartis for the development, manufacture and commercialization of 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.
