Idenix Pharmaceuticals, a Cambridge, Mass.-based biopharmaceutical company focused on human viral diseases, has been granted Fast Track designation by the FDA for IDX719 for the treatment of chronic hepatitis C infection (HCV).
"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," said Ron Renaud, president and CEO 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."
IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV patients. To date, IDX719 has been safe and well tolerated after single and multiple doses of up to 100mg in healthy volunteers (n=36; up to seven days duration) and HCV-infected patients (n=69; up to three days duration).