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news.Achillion has reported additional preliminary data from its on-going phase 1b clinical trial of ACH-1625. The results demonstrated that the second dosing cohort receiving treatment with ACH-1625 achieved a mean 4.25 log10 reduction in HCV RNA after five-day monotherapy, with continued good safety and tolerability in patients with hepatitis C (HCV).
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ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
HCV-infected subjects in the second dosing cohort (n=9, randomized to 6 active drug, 3 placebo) received doses of 500mg BID of ACH-1625. Preliminary results showed that a mean reduction in viral load of 4.25 log10 was achieved in the treatment group, as compared to a mean reduction of 0.29 log10 in the placebo group.
Safety results from this dosing group were similar to those observed in both the phase 1a segment of the trial and in the first cohort of HCV-infected subjects. Sustained viral suppression was also similar to the first cohort, with patients maintaining a mean reduction of more than 3.0 log10 from baseline through day 12, 7 days after dosing was completed and the last day of viral load measurement in the study.
In December 2009, Achillion announced proof-of-concept data from this phase 1b study. Subjects in the first dosing cohort of HCV-infected patients received doses of 600mg 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, electrocardiograms (ECGs), or laboratory evaluations. 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.
Michael Kishbauch, chief executive officer of Achillion, said: “We are quite pleased to see that these data corroborate and support the preliminary positive data from the first cohort of the study even at this lower dose. ACH-1625 continues to demonstrate a dramatic reduction in viral load after 5 days of monotherapy, and importantly, showed continued suppression of viral load after drug discontinuation. This is significant as it could be a distinguishing feature and competitive advantage for our compound in comparison to other HCV therapeutics.”