Valopicitabine (NM283) Combined with Pegylated Interferon Demonstrated Significantly Greater Suppression of Hepatitis C Virus (HCV) Replication in Treatment-Refractory Patients Compared to Retreatment with Ribavirin Plus Pegylated Interferon
Friday November 11, 11:00 am ET
Press Release Source: Idenix Pharmaceuticals, Inc.
SAN FRANCISCO, Nov. 11 /PRNewswire-FirstCall/ --
Valopicitabine combined with pegylated interferon demonstrated significantly greater viral suppression after 12 weeks of treatment compared to retreatment with ribavirin plus pegylated interferon in chronic hepatitis C, genotype 1 patients who were non- responders to previous therapy.
Dr. Christopher O'Brien, Professor of Clinical Medicine at the University of Miami and a principal investigator in an ongoing phase IIb clinical trial of valopicitabine, will present 12-week data from this phase IIb clinical trial on Monday, November 14, 2005 at 9:00 a.m. (PST) at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) held in San Francisco.
Valopicitabine, a novel polymerase inhibitor, is being developed by Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.
"At 12 weeks, the combination of valopicitabine plus Pegasys® produced a statistically significant improvement in suppression of hepatitis C virus (HCV) replication and a significantly higher proportion of patients achieving an early virologic response (EVR) compared to patients retreated with Pegasys® and ribavirin," said Dr. O'Brien. "These are promising results, particularly for the many treatment-refractory patients in urgent need of new therapeutic options," he said.
The phase IIb clinical trial in treatment-refractory patients is designed to evaluate different dosing regimens of valopicitabine in combination with pegylated interferon and to compare this combination with the combination therapy of pegylated interferon plus ribavirin. At 12 weeks of treatment, the two higher-dose arms of valopicitabine plus Pegasys® showed significantly greater suppression of serum HCV RNA compared to the ribavirin plus Pegasys® retreatment arm (p = 0.01). At week 12, mean HCV RNA reductions in the two high-dose arms of valopicitabine plus Pegasys® were 2.5 log10 and 2.8 log10, with 63 percent and 71 percent of patients achieving an EVR. In comparison, patients in the Pegasys® plus ribavirin retreatment control arm showed a mean HCV RNA reduction of 1.9 log10, with 41 percent of patients achieving an EVR. EVR is defined as a greater than 2 log10 reduction in viral load from baseline.
"These encouraging data support continued evaluation of combination treatment with valopicitabine and pegylated interferon in both treatment- refractory and treatment-naive hepatitis C patients," commented Nathaniel Brown, M.D., executive vice president of clinical development and chief medical officer of Idenix. "We look forward to initiating our phase III program for valopicitabine in treatment-refractory patients in early 2006."
In the phase IIb clinical trial, valopicitabine has demonstrated satisfactory safety and tolerance overall. A low percentage of patients on valopicitabine have discontinued due to adverse events. Two serious adverse events were considered attributable to combination treatment with valopicitabine plus pegylated interferon (anemia and dehydration) and both resolved. To date, there has been no predominant treatment-limiting adverse event or laboratory abnormality observed for combination treatment with valopicitabine and pegylated interferon.
Idenix's Hepatitis C Clinical Development Program
At the end of November, Idenix anticipates reviewing with the FDA the available data from the valopicitabine clinical development program, including data from this phase IIb clinical trial during an end-of-phase II meeting. This meeting will help the company define the optimal protocol for the phase III program for valopicitabine in treatment-refractory patients. Idenix currently anticipates initiating a multinational phase III program in treatment-refractory patients in the first quarter of 2006. A 48-week phase IIb clinical trial evaluating valopicitabine in treatment-naive patients is currently ongoing and enrollment is expected to be completed by year end 2005.
About Valopicitabine
Valopicitabine, which is administered
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