The FDA has granted fast track designation for 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 is currently being evaluated in a Phase I trial.
Achillion president and chief executive officer Michael Kishbauch said fast track designation highlights ACH-3102's attributes that include pan-genotypic coverage of HCV and potential for maintained activity against NS5A mutant strains of HCV.
"We are excited to leverage the superior profile of ACH-3102 in combination with our Phase 2 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," Kishbauch added.
Fast Track designation was requested for ACH-3102 for its potential to provide improved safety, potent antiviral activity in vitro against HCV genotypes 1 through 6 and low potential for drug-drug interactions.
