December 21, 2009 (FinancialWire) — Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) reported proof of concept data from the preliminary results of its phase 1b clinical trial of ACH-1625, demonstrating that treatment with ACH-1625 achieved a mean 3.94 log10 reduction in HCV RNA after five-day monotherapy, with continued good safety and tolerability in patients with hepatitis C . ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.

In June 2009, Achillion initiated dosing in a randomized, double-blind, placebo-controlled phase 1a/1b clinical trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-1625 after single and multiple ascending oral doses in healthy volunteers and oral repeat doses for 5 days in subjects with hepatitis C infection. The trial is taking place in Europe and will enroll at least 54 subjects, including both healthy volunteers and HCV-infected patients.

In September 2009, Achillion announced positive results from the phase 1a segment of the study. Subjects in the phase 1a single ascending dose segment of the study received single doses of ACH-1625 ranging from 50 mg to 2000 mg. Subjects in the phase 1a multiple ascending dose segment of the study received 5 days of ACH-1625 up to a maximal dose of 2000 mg per day.

Preliminary data from the SAD and MAD trial segments demonstrated ACH-1625 was well tolerated at all doses and there were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms, or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship.

Achillion announced proof of concept data from the preliminary results of the phase 1b segment of the study. Subjects in this first dosing cohort of HCV-infected patients received doses of 600 mg BID (n=9, randomized to 6 active drug, 3 placebo). Preliminary results showed that a mean reduction in viral load of 3.94 log10 was achieved in the treatment group, as compared to a mean reduction of 0.22 log10 in the placebo group. All subjects in the treatment group had viral load decline between 3.0 and 4.5 log10, and two subjects reached undetectable levels of HCV RNA. Safety results from this dosing group were similar to those observed in the phase 1a segment of the trial. There were no serious adverse events, no clinically significant changes in vital signs, ECGs, or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship.

Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 2.0 log10 from baseline through day 12, the last day of viral load measurement in the study.

Preliminary analysis of viral dynamics of ACH-1625 demonstrates a very rapid reduction in HCV RNA levels after the first dose. ACH-1625 displays high efficiency for inhibition of viral production, with mean efficiency of 0.9994 out of maximal efficiency of 1.0000.

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