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news.Achillion Pharmaceuticals has released additional preliminary data from its Phase 1b clinical trial of ACH-1625, which demonstrated that both the third and fourth patient cohorts receiving treatment with ACH-1625 achieved meaningful reductions in HCV RNA after five-day monotherapy, with continued safety and tolerability in patients with hepatitis C (HCV).
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Achillion Pharmaceuticals said that the subjects in the third cohort of HCV-infected patients received doses of 200mg twice-daily (randomised to 6 active drug, 3 placebo) for five days. Preliminary results showed that a mean maximum reduction in viral load of 3.86 log10 was achieved in the treatment group, as compared to a mean rise of 0.16 log10 in the placebo group.
Reportedly, all subjects in the treatment group had viral load decline greater than 3.0 log10. Mean alanine aminotransferase (ALT) levels decreased over the treatment period and continued to show decline at day 12.
The subjects in the fourth cohort of HCV-infected patients received doses of 600mg once-daily (randomised to 6 active drug, 2 placebo) for five days. Preliminary results showed that a mean maximum reduction in viral load of 3.81 log10 was achieved in the treatment group, as compared to a mean rise of 0.24 log10 in the placebo group.
Additionally, all subjects in the treatment group had viral load decline greater than 3.0 log10. Mean alanine aminotransferase (ALT) levels decreased over the treatment period and continued to show decline at day 12.
Michael Kishbauch, president and CEO of Achillion, said: “We continue to be pleased with the results from these additional cohorts of our ACH-1625 Phase 1b trial with HCV-infected patients.
“It is impressive that at all dose levels ACH-1625 has shown meaningful viral load reduction and sustained viral suppression post treatment course. Importantly, we believe the results from these last two cohorts demonstrated that ACH-1625 was effective at a lower dosing level and in a once-daily dose.
“In summary, these data round out the phase 1b program for ACH-1625 favorably. We remain very encouraged by these results and look forward to advancing the drug into Phase 2 studies in the coming months.”