FDA grants fast track designation to Inhibitex HCV drug
The US Food and Drug Administration (FDA) has designated Inhibitex’s investigation of INX-08189, a potent guanosine nucleotide polymerase inhibitor for the treatment of chronic hepatitis C viral (HCV) infection, as a fast track development program.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV.
INX-189 is a protide of a 2'-C-methylguanosine analogue.
Inhibitex believes the preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
In addition to INX-189, Inhibitex's clinical stage antiviral pipeline includes FV-100, a bicyclic nucleoside inhibitor in Phase II development for the prevention and reduction of shingles-associated pain.
Inhibitex also has additional HCV nucleotide polymerase inhibitors in various stages of preclinical development and has licensed the use of its proprietary MSCRAMM protein platform to Pfizer for the development of active staphylococcal vaccines.
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