Inhibitex has received fast-track designation from the US Food and Drug Administration (FDA) for INX-08189, a guanosine nucleotide polymerase inhibitor intended to treat chronic hepatitis C.
Fast-track designation is designed to help the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and for drugs that show potential to address unmet medical needs.
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The characteristics of INX-08189, including a high genetic barrier to resistance, its pan-genotypic activity, and once-daily oral dosing, facilitated the grant of fast-track designation.
The company has reported interim data from the first two cohorts of its ongoing Phase Ib clinical trial of INX-189, and it expects to complete the trial in the first quarter of 2011.
Hepatitis C is a disease of the liver that affects an estimated 4 million people in US and 170 million worldwide.
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