Biotech Values

[DewDiligence]

Roche Reports Phase-1 HCV Data

[Aside from IDIX, Roche is the main contender in the race to get an HCV nucleoside polymerase inhibitor to market; however, Roche’s R1626 is only in phase-1 and hence is pretty far behind NM283 from IDIX and NVS. (Japan Tobacco and VPHM/WYE have early programs for HCV *non*-nucleoside polymerase inhibitors; and VRTX, SGP, and GILD have early programs for HCV protease inhibitors.)

This PR reports on preliminary data for 18 genotype-1 patients taking R1626 monotherapy for two weeks. In the highest dose tested, the mean reduction in viral load was 1.2 logs, which is nothing spectacular. (Although the PR does not say so, I infer that all most patients in the trial were refractory to standard HCV therapy.) Note that R1626 is dosed twice daily, while NM283 is dosed once daily. All told, R1626 does not look like a serious threat to NM283 in terms of efficacy, but it may possibly have an edge in tolerability and safety.]

http://biz.yahoo.com/prnews/060429/nysa002.html?.v=51

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Saturday April 29, 12:00 pm ET

- Results Strengthen Pipeline for Next Generation of Roche Therapies -

VIENNA, Austria, April 29 /PRNewswire/ -- 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 at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL). Further trials are planned to study how well R1626 works in combination with PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin).

"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."

About the study

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.

The study found:(1)

* 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 log(10) (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.

"Development of R1626 demonstrates our commitment to developing additional treatments for patients living with hepatitis C," said James A. Thommes, M.D., 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."
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