Strong Ph I data for Roche's HCV drug R1626

Swiss drug major Roche says that new clinical data on its investigational hepatitis C polymerase inhibitor R1626 shows viral reductions in patients infected with the difficult-to-treat HCV genotype-1 greater than those observed for other polymerase inhibitors, according to study results presented at the 57th annual meeting of the American Association for the Study of Liver Diseases, held in Boston.

In this Phase I study, 47 patients with genotype-1 hepatitis C were randomized to receive either oral treatment with R1626 twice daily or placebo for 14 days. The final results presented at AASLD included patients who received the higher doses of R1626 at 3,000mg or 4,500mg twice a day and revealed clinically-significant mean reductions in serum HCV RNA of 2.6 and 3.7 log(10) with R1626 at 3,000mg and 4,500mg, respectively.

The agent also showed good tolerability following dosing for 14 days of up to 3,000mg twice-daily, Roche noted. No patient was prematurely withdrawn from the study, although increasing numbers of adverse events were noted at higher dose levels along with reversible mild-to-moderate hematological changes.