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IDX719 Receives Fast Track Designation for Treatment of Chronic Hepatitis C Infection
Under the FDA Modernization Act of 1997, a Fast Track designation may expedite the review of a drug that is intended for the treatment of a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file a New Drug Application (NDA) on a rolling basis.
This permits the FDA to review the filing as it is received, rather than waiting for the entire submission before starting the review process. IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. IDX719 was safe and well tolerated after single and multiple doses of up to 100 mg in healthy volunteers (n = 36; up to 7 days duration) and in HCV-infected patients (n = 69; up to 3 days duration). No treatment-emergent serious adverse events were reported.
IDX719 has demonstrated pan-genotypic antiviral activity in HCV-infected patients. Maximal viral load reductions were greater than 3 log10 after a single 100-mg dose in an exploratory cohort of genotype 1, 2, and 3 HCV-infected patients. These results were confirmed in a subsequent proof-of-concept, 3-day monotherapy study. After administration of IDX719 (100 mg once daily) for 3 days, mean maximal viral load reductions were greater than 3.4 log10 in genotype 1, 3, and 4 HCV-infected patients. Genotype 2 HCV-infected patients showed mean maximal viral load reductions of 2.0 log10.
Idenix is conducting pharmacokinetic and sequencing analyses to further characterize these results.
For more information, visit the Idenix Web site for more information.