New Oral Polymerase Inhibitor Shows Promising Results in Chronic Hepatitis C Patients

R1626, one of a new class of hepatitis C therapies called polymerase inhibitors, demonstrates an antiviral effect by achieving clinically significant viral load reductions in chronic hepatitis C patients with genotype 1, the most difficult to treat genotype, according to preliminary data presented by Dr. Peter Ferenci and colleagues at the 41^st EASL in Vienna.

“Data from this study evaluating R1626 are encouraging,” said Frederick G. Thompson, President and Chief Executive Officer of the American Liver Foundation. “Since genotype 1 patients are the most common in the United States and also the most difficult to treat, there is a real need for a product that could potentially improve treatment outcomes.”

In this phase I study, patients are randomized to receive either oral treatment with R1626 or placebo for 14 days with 14 days of follow-up. Preliminary data were presented on the 18 patients who received 500 mg or 1,500 mg twice daily doses of R1626. The study is still ongoing and higher doses of R1626 are being evaluated.

Primary study results are as follows:

At the 1,500 mg twice daily dose, R1626 was associated with clinically significant reductions from baseline in serum HCV RNA (a measure of how much virus is in the blood) of 1.2 log10 (group mean) At both 500 mg and 1,500 mg twice daily, R1626 was well tolerated in patients, with no serious adverse events and no premature withdrawals.

Further trials are planned to study how well R1626 works in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin).

“Development of R1626 demonstrates our commitment to developing additional treatments for patients living with hepatitis C,” said James A. Thommes, MD, Senior Medical Director, Roche. “Pegasys is the preferred pegylated interferon for the management of hepatitis C in the United States today. Furthermore, we are undertaking additional collaborations and partnerships with other companies to continue to seek improvements of treatment outcomes,” said Dr. Thommes.

05/02/06

Reference
S Roberts, G Cooksley, D Shaw, and others. INTERIM RESULTS OF A MULTIPLE ASCENDING DOSE STUDY OF R1626, A NOVEL NUCLEOSIDE ANALOG TARGETING HCV POLYMERASE IN CHRONIC HCV PATIENTS  Abstract 731. 41^st EASL. April 26-29, 2006. Vienna, Austria.