Achillion initiates dosing in Phase Ib hepatitis C virus study

Wed. September 30, 2009; Posted: 08:31 AM

Sep 30, 2009 (Datamonitor via COMTEX) -- ACHN | Quote | Chart | News | PowerRating -- Achillion Pharmaceuticals, a developer of small molecule drugs, has completed the Phase Ia trial of its ongoing clinical trial of ACH-1625, a protease inhibitor for the treatment of hepatitis C virus, or HCV, infection, and has begun dosing HCV-infected patients in the Phase Ib segment of the trial.

The Phase Ia/Ib clinical trial is a randomized, double-blind, placebo-controlled 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 five days in subjects with hepatitis C infection.

The trial is taking place in Europe and is designed to enroll at least 54 subjects, including both healthy volunteers and HCV-infected patients. The trial is anticipated to be completed in the first quarter of 2010.

Subjects in the Phase Ia single ascending dose segment of the study received single doses of ACH-1625 ranging from 50mg to 2,000mg. Subjects in the Phase Ia multiple ascending dose segment of the study received five days of ACH-1625 up to a maximal dose of 2,000mg per day.

ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion, with the objective of developing a best-in-class protease inhibitor for the treatment of HCV infection featuring potency, safety, tolerability and convenient once-daily dosing.

Michael Kishbauch, Achillion's president and CEO, said: "This first clinical trial of ACH-1625 has proceeded exactly as planned and we are quite pleased and encouraged with the results to date. The HCV-infected cohort of the trial has begun, and we expect it should conclude within the next few months. We are eager to demonstrate ACH-1625's efficacy and anticipate being able to announce those data early next year."

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