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New HCV and HBV Drugs
  Initiates Clinical Program for Hepatitis C Drug Candidate
SAN FRANCISCO, Jan. 8 /PRNewswire/ -- Today at the 21st Annual JP Morgan H&Q Healthcare Conference, Idenix Pharmaceuticals announced plans to initiate, prior to the end of this month, a phase I/II clinical trial of NM283, Idenix's drug candidate for the treatment of hepatitis C infection (HCV). Jean-Pierre Sommadossi, Ph.D., Idenix Pharmaceuticals' Chairman and Chief Executive Officer, also announced the commencement of a phase III clinical trial for telbivudine, Idenix's most advanced drug candidate for the treatment of hepatitis B infection (HBV), and provided updates on the Company's other preclinical and clinical programs in hepatitis and HIV.
editorial note from Jules Levin: although the press release does not mention it i believe this drug is a polymerase inhibitor, from my previous discussions with company officials.
Hepatitis C program
NM283, an oral, small molecule, once-daily treatment, is Idenix's third hepatitis drug candidate to enter clinical trials and the Company's first drug candidate for the treatment of HCV. Idenix filed an Investigational New Drug Application (IND) for NM283 with the U.S. Food and Drug Administration (FDA) in November 2002. In preclinical toxicology studies, NM283 exhibited a good safety profile and in a primate model, NM283 demonstrated potent and consistent suppression of human-derived HCV. The first clinical trial of NM283 is a phase I/II randomized study. This study is designed to evaluate safety and short-term antiviral activity of NM283 in adults with chronic hepatitis C infection and to assess optimal dosing levels of NM283 for future large-scale clinical trials. The study will be conducted at multiple sites in the United States and will include previously untreated patients, patients with genotype 1 HCV infection, an infection type which has a low response rate to existing treatments, and patients who have failed prior interferon-based treatment.
Hepatitis B program
Telbivudine, Idenix's lead drug candidate for the treatment of hepatitis B infection (HBV) is currently in phase III clinical evaluation. The phase III program will include 1,200 patients from approximately 120 clinical research sites in Asia, Europe and North America. The phase III program will evaluate the safety and efficacy of telbivudine compared with standard treatment in patients with HbeAg+ and HbeAg- compensated liver disease.
Interim 24-week data from an ongoing international phase IIb clinical trial, presented in November at the 2002 Conference of the American Association for the Study of Liver Disease, indicate a median reduction in serum virus load for all LdT-containing arms of greater than 6 log10 or a million fold. In patients receiving lamivudine alone, a median reduction of 4.67 log10 occurred. To date, LdT treatment appears to have been well tolerated by patients and no treatment-limiting or dose-related adverse events have been observed.
Valtorcitabine, Idenix's second drug candidate for the treatment of HBV, currently in phase I/II clinical trials, is being developed for use as a fixed dose combination therapy with telbivudine. Idenix anticipates that combination therapy will be required for treatment of certain chronically infected HBV patient populations that may not respond well to treatment with a single agent.
"We are very pleased with the rapid and significant progress achieved in our telbivudine and valtorcitabine hepatitis B clinical drug development programs to date", said Dr. Sommadossi. "The entry of NM283 into clinical trials for the treatment of hepatitis C infection substantially enhances our pipeline within this focused therapeutic area and reaffirms our commitment to the field of hepatology and infectious disease."
About Idenix
Idenix Pharmaceuticals, Inc., formerly Novirio Pharmaceuticals Limited, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). The Company has targeted each of these viral diseases due to the substantial global need for improved therapy. It is estimated that more than 600 million people are infected with HBV, HCV, or HIV worldwide. Currently available treatments for these diseases have failed to produce long-term durable responses or favorable clinical outcomes in a large percentage of patients. Idenix is developing telbivudine in collaboration with Sumitomo Pharmaceuticals Co. Ltd. for Japan and selected Asian markets.
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