Achillion Pharmaceuticals Inc., focused on developing treatments for infectious disease, today announced it has begun dosing in a phase 1 clinical trial of ACH-2684 for the treatment of chronic hepatitis C virus (HCV) infection.
The study is a randomized, double-blind, placebo-controlled trial designed to determine the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2684, and will include up to 78 healthy volunteers and up to 40 HCV-infected patients.
“This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-2684 in humans,” Elizabeth A. Olek, D.O., vice president and chief medical officer of Achillion stated in the press release. “It will also provide Achillion with important preliminary efficacy data against HCV genotypes 1 and 3, and help us to select doses for subsequent clinical development.”
The trial is comprised of three segments to asses single ascending oral doses in healthy volunteers; a 14-day multiple ascending dose in healthy volunteers; and three days of oral ascending repeat doses in subjects with either genotype 1 or genotype 3 HCV.
“We are very excited to take ACH-2684 into the clinic and advance what we hope will be a unique pan-genotypic, once-daily protease inhibitor,” said Michael D. Kishbauch, president and CEO of Achillion.
In addition to today’s news, the company is preparing to initiate the 12-week segment of its phase II trial for the company’s lead ACH-1625 protease inhibitor, as well as a phase I trial of its ACH-2928 NS5A inhibitor.
“We believe we remain poised to deliver a trio of important HCV clinical milestones near the end of this year, namely, 12-week EVR results on ACH-1625 and human proof-of-concept data on both ACH-2684 and ACH-2928. These are all important components in our ultimate strategy of becoming a leader in the development of HCV combination therapies involving our protease and NS5A inhibitors,” Kishbauch stated.
For more information visit www.achillion.com