New Haven drug developer Achillion Pharmaceuticals Inc. says it has begun two human clinical trials in the U.S. and Europe to determine the dosing effectiveness of a prototype treatment against the hepatitis C virus.
Some 120 patients with chronic hepatitis C participating in the two double-blind trials — one to run 28 days, the other 12 weeks — will be randomly dosed with small-molecule ACH-1625 drug or with a placebo.
The trial will determine the dosing at which ACH-1625 blocks a particular enzyme the hepatitis C virus needs to replicate, Achillion officials say.
Results of the 28-day trial will be disclosed in the first quarter of 2011; the 12-week study findings will come near the end of next year.
“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,” said Elizabeth A. Olek, Achillion’s chief medical officer. “The results will also provide important combination data for use of ACH-1625 with standard of care.”
Achillion officials are eager to prove their treatment, with a more convenient dosing, is a safer and more tolerable viral suppressant over a longer period.
