Recent HCV Pipeline Accomplishments
"Throughout 2011 and into 2012, we consistently achieved the milestones that will enable us to initiate a combination study evaluating a proprietary all-oral, interferon-free trial with our lead protease inhibitor, ACH-1625, in combination with our second generation NS5A inhibitor, ACH-3102, later this year," commented Michael Kishbauch, President and Chief Executive Officer of Achillion.
* Reported 100% complete early virology response (cEVR) following interim analysis of 35 patients enrolled in a Phase 2a 12-week study evaluating ACH-1625 in combination with pegylated interferon plus ribavirin (P/R) for the treatment of chronic hepatitis C (HCV) genotype 1 treatment-naive patients. Enrollment in this trial has been completed;
* Completed three and six-month preclinical toxicity studies with ACH-1625, with nine-month studies to be completed in the first quarter;
* Reported clinical proof-of-concept with ACH-1625 against HCV genotype 3;
* Received Fast Track designation for ACH-1625 for the treatment of HCV;
* Achieved Phase 1 proof-of-concept with ACH-2684, a pan-genotypic protease inhibitor;
* Achieved Phase 1 proof-of-concept with ACH-2928, a first generation NS5A inhibitor; and
* Completed IND-enabling studies to support the filing of an IND for a second generation NS5A inhibitor, ACH-3102.
Mr. Kishbauch continued, "The clinical profile of ACH-1625 continues to excel, featuring not only 100% cEVR against genotype 1 HCV, but apparent pan-genotypic activity as demonstrated in a pilot study against HCV genotype 3, and lack of viral breakthrough with its continued suppression of known resistant variants of HCV. This extremely robust drug profile for ACH-1625 has led us to complete all the additional activities necessary to enter registrational clinical trials in 2013, including completion of a commercially feasible formulation and a full non-clinical toxicology package