The clinical trial is a Phase IIa, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability and antiviral activity of oral ACH-1625 in combination with pegylated interferon alfa-2a and ribavirin after 28 days of dosing and after 12 weeks of dosing in subjects with chronic hepatitis C virus genotype 1. The trial will take place in the United States and Europe and is designed to enroll approximately 120 HCV-infected patients. The 28-day and 12-week trial data are anticipated to be announced in the first and fourth quarters of 2011, respectively.
“This Phase II clinical trial will allow us to establish the most appropriate once-daily dose to use in longer-term trials, and will augment our existing safety database for ACH-1625 in humans,” stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. “The results will also provide important combination data for use of ACH-1625 with standard of care. We anticipate that the 28-day segment of the trial will provide us with rapid viral response (RVR) data early next year, and that the 12-week segment will provide extended viral response (cEVR) data by the end of next year.”
“The initiation of Phase II dosing for ACH-1625 is a very important step in further solidifying this compound’s profile as a potentially best-in-class protease inhibitor for HCV treatment,” said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. “We believe ACH-1625 has the potential to provide an improved safety and tolerability profile, a more convenient dosing schedule and an extended period of viral suppression compared to currently available treatments for HCV-infected patients.”
SOURCE Achillion Pharmaceuticals, Inc.