IDX719 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection
Idenix Pharmaceuticals, Inc, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, recently announced the FDA has granted Fast Track designation for IDX719 for the treatment of chronic hepatitis C infection.
Idenix Pharmaceuticals, Inc, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, recently announced the FDA has granted Fast Track designation for IDX719 for the treatment of chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pangenotypic activity in a recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV patients.
"We are pleased and encouraged by the receipt of Fast Track designation from the FDA for IDX719 as we believe this reflects the critical need for new treatment regimens to address HCV infection," stated Ron Renaud, president and chief executive officer of Idenix. "We remain focused on executing our goal of creating an interferon-free direct acting antiviral combination to cure HCV for a patient population that currently has limited treatment options. As previously reported, we are on track to initiate a phase II combination study of IDX719 with IDX184, our other lead HCV product candidate, by the end of this year."
Under the FDA Modernization Act of 1997, Fast Track designation may potentially 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 prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which would reduce the length of the standard FDA review period.
IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, IDX719 has been 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 HCV-infected patients (n=69; up to 3 days duration). There have been no treatment-emergent serious adverse events reported in the program. IDX719 has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients. Maximal viral load reductions were > 3 log10 after a single 100 mg dose in an exploratory cohort of genotype 1, 2 and 3 HCV-infected patients. These results have been confirmed in a subsequent proof-of-concept, three-day monotherapy study. After administration of 100 mg IDX719 once daily for 3 days, mean maximal viral load reductions were > 3.4 log10 in genotype 1, 3 and 4 HCV-infected patients. There was greater variability in responses among genotype 2 HCV-infected patients, who had mean maximal viral load reductions of 2.0 log10. The Company is currently conducting pharmacokinetic and sequencing analyses to further characterize these results.
Idenix Pharmaceuticals, Inc, headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with HCV. For further information about Idenix, please refer to www.idenix.com.
Idenix's HCV pipeline:
SOURCE: Idenix Pharmaceuticals