You are here

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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug