The US Food and Drug Administration (FDA) has granted fast track designation to Achillion Pharmaceuticals’ ACH-1625 drug, which is being evaluated in a Phase II clinical trial as a treatment for chronic hepatitis C virus (HCV).
ACH-1625 is a once-daily HCV protease inhibitor and an open chain, non-covalent, reversible inhibitor of NS3 protease, designed and synthesised based on crystal structures of enzyme / inhibitor complex. The fast track designation will provide improved safety and tolerability compared with the current standard of care, convenient once-daily dosing, broader genotypic coverage of HCV, improved drug-drug interaction profile with greater potential to treat HCV patients and development in a once-daily interferon-free oral combination.
Achillion president and CEO Michael Kishbauch said they look forward to initiate an interferon-free, all-oral combination clinical study evaluating its protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of 2012. Earlier preclinical studies reported that ACH-1625 showed high potency, unique pharmacokinetic properties and a good safety profile at high drug exposures.
In the first segment of a Phase 2a clinical study, treatment-naive genotype 1 HCV patients received doses of 200mg, 400mg, or 800mg of ACH-1625 in combination with pegylated interferon and ribavirin (SOC) and achieved a rapid viral response (RVR) of 75 to 81% compared to an RVR of 20% for patients receiving SOC only.
The second segment of the Phase 2a study is a randomised double-blind trial, assessing the safety, tolerability and antiviral activity of once daily ACH-1625, at doses of 200mg, 400mg or 800mg, in combination with SOC for 12 weeks of dosing.
According to the American Association of Liver Disease, more than 170 million people are infected with HCV worldwide, of which 80% of individuals become chronically infected following exposure to the virus.
Achillion is an innovative pharmaceutical company focused on the discovery and development of small molecule drugs to combat the most challenging infectious diseases, including hepatitis C and resistant bacterial infections.