Preclinical characteristics of the hepatitis C virus NS3/4A protease inhibitor ITMN-191 (R7227)

Antimicrob Agents Chemother. 2008 Dec;52(12):4432-41. doi: 10.1128/AAC.00699-08. Epub 2008 Sep 29.

Abstract

Future treatments for chronic hepatitis C virus (HCV) infection are likely to include agents that target viral components directly. Here, the preclinical characteristics of ITMN-191, a peptidomimetic inhibitor of the NS3/4A protease of HCV, are described. ITMN-191 inhibited a reference genotype 1 NS3/4A protein in a time-dependent fashion, a hallmark of an inhibitor with a two-step binding mechanism and a low dissociation rate. Under preequilibrium conditions, 290 pM ITMN-191 half-maximally inhibited the reference NS3/4A protease, but a 35,000-fold-higher concentration did not appreciably inhibit a panel of 79 proteases, ion channels, transporters, and cell surface receptors. Subnanomolar biochemical potency was maintained against NS3/4A derived from HCV genotypes 4, 5, and 6, while single-digit nanomolar potency was observed against NS3/4A from genotypes 2b and 3a. Dilution of a preformed enzyme inhibitor complex indicated ITMN-191 remained bound to and inhibited NS3/4A for more than 5 h after its initial association. In cell-based potency assays, half-maximal reduction of genotype 1b HCV replicon RNA was afforded by 1.8 nM; 45 nM eliminated the HCV replicon from cells. Peginterferon alfa-2a displayed a significant degree of antiviral synergy with ITMN-191 and reduced the concentration of ITMN-191 required for HCV replicon elimination. A 30-mg/kg of body weight oral dose administered to rats or monkeys yielded liver concentrations 12 h after dosing that exceeded the ITMN-191 concentration required to eliminate replicon RNA from cells. These preclinical characteristics compare favorably to those of other inhibitors of NS3/4A in clinical development and therefore support the clinical investigation of ITMN-191 for the treatment of chronic hepatitis C.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antiviral Agents* / chemistry
  • Antiviral Agents* / metabolism
  • Antiviral Agents* / pharmacology
  • Carrier Proteins / antagonists & inhibitors*
  • Cell Line, Tumor
  • Drug Evaluation, Preclinical
  • Drug Synergism
  • Hepacivirus / drug effects*
  • Hepacivirus / enzymology*
  • Hepacivirus / genetics
  • Hepacivirus / physiology
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / pharmacology
  • Intracellular Signaling Peptides and Proteins
  • Liver / metabolism
  • Macaca fascicularis
  • Polyethylene Glycols / pharmacology
  • Protease Inhibitors* / chemistry
  • Protease Inhibitors* / metabolism
  • Protease Inhibitors* / pharmacology
  • Rats
  • Recombinant Proteins
  • Viral Nonstructural Proteins / antagonists & inhibitors*
  • Viral Proteins / antagonists & inhibitors*
  • Virus Replication / drug effects

Substances

  • Antiviral Agents
  • Carrier Proteins
  • Interferon alpha-2
  • Interferon-alpha
  • Intracellular Signaling Peptides and Proteins
  • NS3 protein, hepatitis C virus
  • NS4A cofactor peptide, Hepatitis C virus
  • Protease Inhibitors
  • Recombinant Proteins
  • Viral Nonstructural Proteins
  • Viral Proteins
  • Polyethylene Glycols
  • peginterferon alfa-2a