Roche's Oral Polymerase Inhibitor Shows Robust Antiviral Efficacy in Treatment of Chronic Hepatitis C
02/11/2007 12:35
PR Newswire
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.
About Roche
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? 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?.
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.
References:
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, +44(0)20-843-99-406