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Achillion Announces Positive RVR Results With ACH-1625 To Treat Chronic Hepatitis C

NEW HAVEN, Conn., March 30, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced top-line results from its on-going Phase 2a clinical trial of ACH-1625 dosed once daily (QD) in combination with Pegasys ® (peginterferon alfa-2a) and Copegus ® (ribavirin), a current standard of care (SOC) in patients with chronic hepatitis C (HCV) infection. The analysis demonstrated that 75-81% of patients receiving ACH-1625 achieved rapid virologic response (RVR) with a promising safety and tolerability profile. ACH-1625 is an inhibitor of HCV NS3 protease that was discovered by and is being developed by Achillion.

Study Design

In this first of a two segment Phase 2a trial, a total of 64 patients were enrolled and randomized across three doses of ACH-1625 given once daily (200mg, 400mg or 800mg) or placebo with peginterferon alfa-2a and ribavirin, and were dosed for 4 weeks of therapy. Patients then continue on SOC for up to an additional 44 weeks. Subjects were randomized and stratified by HCV genotype and IL28B genotype. 

Top-line Results

The majority of the 64 patients enrolled were HCV genotype 1a (73%), with a smaller percentage of HCV genotype 1b patients (25%). A total of 75% of the patients enrolled were genotype CT/TT, a marker of the patient's diminished response to interferon, and 25% were genotype CC. All patients receiving 4 weeks of treatment with ACH-1625 demonstrated continuous and substantial declines in HCV RNA with no viral breakthrough during therapy at any of the doses. Preliminary results for the 64 patients enrolled demonstrate RVR percent and viral load reduction as follows:
  ACH-1625 Placebo
  200 mg QD N=16 400mg QD  N=16 800 mg QD N=17 N=15
Week 4 RVR Subjects with HCV RNA < 25 IU/mL 13/16 (81%) 12/16 (75%) 13/17 (76%) 3/15 (20%)
Mean maximum HCV RNA decline through Week 4 (log10) 4.90 4.63 4.96 2.25

Safety results from a planned safety analysis included 56 patients from this segment of the trial and indicated that adverse events (AEs) were similar to those observed in the previously reported Phase 1a and 1b trials of ACH-1625. Over 4 weeks of co-administration of ACH-1625 with SOC, there were no discontinuations due to adverse events and there were no serious adverse events (SAEs) reported. Most reported AEs in patients receiving ACH-1625 were classified as mild to moderate and were transient. The most common AEs were consistent with peginterferon alfa-2a and ribavirin.   

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