protease inhibitor recieves fast track

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ACH-1625 Protease Inhibitor Receives Fast Track For The Treatment Of HCV
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Wednesday, January 4, 2012
Posted by New HCV Drugs
File Under ACH-1625

ACH-1625 Receives Fast Track Designation for the Treatment of Chronic Hepatitis C



About ACH-1625

ACH-1625 is a HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM.

In the first segment of a Phase 2a clinical study, treatment-naïve genotype 1 HCV patients received doses of 200 mg, 400 mg, or 800 mg of ACH-1625 in combination with pegylated interferon and ribavirin (SOC) and achieved a rapid viral response (RVR) of 75 — 81% compared to an RVR of 20% for patients receiving SOC only. ACH-1625 was well tolerated at all doses with no serious adverse events reported and adverse events which were reported as mild to moderate and transient. The second segment of this Phase 2a, randomized, double-blind trial is evaluating the safety, tolerability and antiviral activity of once daily ACH-1625, at doses of 200 mg, 400 mg or 800 mg, in combination with SOC for 12 weeks of dosing. The primary endpoint for this trial is complete early virological response (cEVR). Following 12 weeks of therapy, patients will continue to receive an additional 12 weeks of pegylated interferon alfa-2a and ribavirin and be eligible to discontinue treatment at week 24 if they achieve extended rapid virologic response (eRVR) at week 12. Patients who do not achieve an eRVR will continue to receive SOC until week 48