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.

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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.

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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.

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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.