In 2011, Achillion discovered and nominated the investigational compound, ACH-3102. ACH-3102 is a structurally distinct, pan-genotypic, second-generation NS5A inhibitor with an improved barrier to resistance. ACH-3102 has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C (HCV). An ongoing Phase 2 clinical trial is evaluating the all-oral, interferon-free combination of ACH-3102 and the next-generation protease inhibitor, sovaprevir, with and without ribavirin (RBV), for 12 and 8 week treatment durations, in genotype 1 HCV patients. Initial study results are expected during the 2nd half of 2013. Achillion retains worldwide commercial rights to ACH-3102.
• ACH-3102 has picomolar potency and has displayed pan-genotypic activity against all subtypes of HCV in vitro
• ACH-3102 has an extended half-life that supports once-daily dosing
• ACH-3102 was shown to be safe and well tolerated with no serious adverse events reported through 12 weeks of treatment in a pilot, Phase 2a, interferon-free clinical study
• ACH-3102 has demonstrated robust antiviral activity with a greater than 3.7 log10 mean maximal reduction of HCV RNA with a single dose in genotype (GT) 1a patients, the harder to treat GT1 subtype
• Due to the distinct profile of ACH-3102, it is the first NS5A inhibitor to be evaluated in combination with only RBV in clinical study and achieve a sustained virologic response (SVR) in GT1b HCV-infected patients
• ACH-3102 provides a high pharmacologic barrier to resistance with enhanced activity against the most common resistant variants to emerge during NS5A treatment, including those occurring at positions 31 and 93
• In clinical studies to date, there have been no on-treatment viral breakthroughs in GT1b or GT1a HCV patients evaluated
• In vitro testing has shown ACH-3102 is synergistic when combined with other inhibitors of HCV including protease inhibitors
For more information about the second-generation NS5A inhibitor, ACH-3102, please visit the Data Overview section
ACH-3102 is an investigational compound. Its safety and efficacy have not been established.