The FDA has granted Fast Track designation to Achillion Pharmaceuticals’ ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV).
ACH-3102 is a pan-genotypic second-generation NS5A inhibitor against HCV that was discovered by Achillion and is currently being evaluated in a phase I clinical trial. Achillion requested Fast Track designation for ACH-3102’s potential to provide improved safety as compared to the current standard of care; potential for development in a once daily interferon-free fixed dose combination; potent antiviral activity in vitro against HCV genotypes 1 through 6; and low potential for drug-drug interactions and therefore greater potential to treat HCV patients with co-morbidities, co-infected with HIV, or pre- or post-liver transplantation.
ACH-3102 is a structurally distinct small molecule compound that has demonstrated potent inhibition of the NS5A protein across all genotypes of HCV in preclinical studies. Furthermore, the unique chemical structure of ACH-3102 has resulted in enhanced potency in vitro against resistant mutants that have emerged during clinical studies with first generation NS5A inhibitors.
"We are very pleased with the granting of a Fast Track designation for ACH-3102, which we believe highlights this second-generation NS5A inhibitor's attributes that include pan-genotypic coverage of HCV and potential for maintained activity against NS5A mutant strains of HCV," said Michael Kishbauch, president and CEO of Achillion. "We are excited to leverage the superior profile of ACH-3102 in combination with our phase II protease inhibitor, ACH-1625, as we seek to create an optimized, potentially best-in-class potent, well-tolerated, once-daily regimen to treat HCV, which will enter combination studies during the third quarter of this year."