02/11/2007 13:35:48 CET
BASEL, Switzerland, November 2 /PRNewswire/ --
-- Roche Progresses R1626 Into Phase IIb Study Called POLI 1
R1626, one of Roche's new investigational drugs for hepatitis C (HCV), has shown promising antiviral efficacy when given in combination with PEGASYS(R) (peginterferon alfa-2a (40KD)) and COPEGUS(R) (ribavirin), according to results being presented at the American Association for the Study of the Liver (AASLD) meeting in Boston(1). After 4 weeks of treatment with the triple combination, the hepatitis C virus could no longer be detected in up to 81% of the HCV-infected patients. Patients receiving the triple combination had a mean decrease in viral load of 5.2 log10 from baseline, indicating a robust and rapid virological response.
R1626 belongs to a class of antivirals called polymerase inhibitors, which are being investigated in combination with the current standard of care, pegylated interferon and ribavirin. The hope is that this potent combination will increase the number of patients who manage to clear the hepatitis C virus from their system and become cured of this disease.
Lack of Resistance Demonstrated
R1626 has also demonstrated a high barrier to the development of resistance, according to a second abstract being presented at the conference(2). Resistance to R1626 was not identified following intensive testing for either 2 weeks of treatment with R1626 as monotherapy or for 4 weeks in patients treated with R1626 in combination with the standard of care.
"The results from this phase IIa study show that R1626 has a profound effect when used in combination with PEGASYS plus COPEGUS," said Dr Paul Pockros (Scripps Clinic, San Diego, California), the lead investigator of the study. "The synergistic antiviral effect of R1626 along with the lack of resistance means that R1626 could be an exciting antiviral treatment option for patients with hepatitis C if a safe and acceptable dosage regimen can be determined in future studies."
The study found(1):
-- Up to 81% of patients treated with R1626 1500 mg BID + PEGASYS + ribavirin had an undetectable HCV viral load by week 4 (mean reduction of 5.2 log10 IU/ml)
-- ALT, a liver enzyme, normalised in approximately 50% of patients in R1626 treatment groups
-- Most reported adverse events were mild to moderate. A higher incidence of grade 4 neutropaenia was reported in R1626 treatment arms (ie, 39% of patients receiving the R1626 1500 mg dose in combination with PEGASYS and ribavirin), and it was the main reason for dose reductions and discontinuations
Further phase II studies are underway to investigate R1626 in combination with PEGASYS plus COPEGUS.
Start of the Phase IIb Trial
As a result of the robust antiviral effect seen in the phase IIa study, R1626 is being progressed into a phase IIb study to further investigate new treatment regimens, in combination with a standard or lower dose of PEGASYS(R) plus a standard dose of COPEGUS(R). This phase IIb trial, called POLI 1, is now open and about to enroll patients in eight countries - Austria, Australia, Canada, France, Germany, Italy, Spain and the US. More information about R1626 and these clinical studies can be found on http://www.roche-trials.com.
"The strong synergistic antiviral effect seen among R1626, PEGASYS and COPEGUS in the Phase IIa study together with the design of the phase IIb study makes me confident that we will find the right balance between the safety and efficacy," said Dr. Stefan Zeuzem, Professor of Medicine at J.W.
Goethe University Hospital, Frankfurt, Germany, and a lead investigator in this Phase IIb study.
About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, is transmitted primarily through blood or blood products. Hepatitis C chronically infects 180 million people worldwide, with an additional three to four million people newly infected each year(3). It is a leading cause of cirrhosis, liver cancer and liver failure, despite being potentially curable. The future of hepatitis C therapy is likely to involve combinations of new small-molecule antiviral drugs and pegylated interferon-based treatment, like PEGASYS.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's largest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, is a market leader in virology and is active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006, sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet at http://www.roche.com.
All trademarks used or mentioned in this release are protected by law.
1. Pockros P. Robust synergistic antiviral effect of R1626 in combination with Peginterferon alfa-2a (40KD), with or without ribavirin - interim analysis results of phase 2a sudy. In: 58th Annual Meeting of the American Association for the Study of Liver Diseases; 2007 November 2-6; Boston, USA; 2007.
2. Le Pogam S. A high barrier to resistance may contribute to the robust antiviral effect demonstrated by R1626 in HCV genotype 1-infected treatment-naive patients. In: 58th Annual Meeting of the American Association for the Study of Liver Diseases; 2007 November 2-6, 2007; Boston, USA; 2007.
3. World Health Organization. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. 2006. (Accessed July 24, 2006, at http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html)
Contact: Janet Kettels, Roche, +1-862-596-9084; Natalie Henson, Axon Communications, 2 Nov. (0) - 20-843-99-406