Inhibitex's Hep C Drug Gets Fast-Tracked

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Inhibitex's Hep C Drug Gets Fast-Tracked

As a result of the need for improved treatments, the FDA granted fast track development to INX-08189, a guanosine nucleotide polymerase inhibitor for treating Hepatitis C.

FDA grants fast track designation to Inhibitex HCV drug

PBR Staff Writer

Published 14 February 2011

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.

Continue reading this entire article:http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-grants-fast-track-designation-to-inhibitex-hcv-drug-140211

http://www.hepatitis-central.com/mt/archives/2011/02/inhibitexs_hep.html