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New HCV and HBV Drugs
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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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