Pharmaceutical Business Review (01/05/12)
The FDA has given Achillion Pharmaceutical's ACH-1625 drug for the treatment of chronic hepatitis C virus a fast track designation. Already being examined in a Phase 2 clinical trial, the drug is a daily single-dose protease inhibitory with an open chain, non-covalent NS3 inhibitor. The first section of the Phase 2a clinical study found that ACH-1625 in combination with pegylated interferon and ribavirin (SOC) produced a substantially higher rapid viral response than was seen in patients only receiving SOC. The second part of the study examined the safety, antiviral activity, and tolerability of ACH-1625 as combined with SOC over the course of a 12-week dosing period. The company is anticipating an interferon-free, all-oral combination clinical study where the protease inhibitor would be combined with a NS5A inhibitor, which is expected in the second half of 2012.

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