Promising Ph IIa data on Tibotec's HCV drug

New clinical data demonstrate the safety and antiviral activity of TMC435, an investigational protease inhibitor being developed by Irish drugmaker Tibotec for chronic hepatitis C virus infection.

Tibotec presented findings recently from three TMC435 studies, including a late-breaker poster on the proof-of-principle Phase IIa trial, OPERA-1, at the American Association for the Study of Liver Disease's Liver meeting in San Francisco.

Mean reductions of HCV RNA from baseline to day seven with TMC435 alone and in triple therapy were 2.63 and 3.47 log10 IU/mL, respectively, in the 25mg arm, and 3.43 and 4.55 log10 IU/mL in the 75mg arm. In the 75mg four-week triple therapy cohort, no viral breakthrough was observed; 9/9 patients achieved HCV RNA below lower limit of quantification (<25 IU/mL) and 8/9 patients achieved undetectable HCV RNA (<10 IU/mL) at day 28 (RVR=89%).