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news.Cambridge, Massachusetts-based Idenix Pharmaceuticals and Swiss drugmaker Novartis AG have revealed that their experimental drug for hepatitis B has achieved its primary goal in a phase III trial.
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According to the companies, the trial showed that telbivudine is as effective in chronic hepatitis B patients as the standard treatment lamivudine after one year of use.
The phase III trial is part of a two-year global study that has enrolled over 1,350 patients in over 130 medical centers worldwide. Idenix and Novartis are hoping to seek marketing approval for their drug from the FDA by the end of 2005.
The World Health Organization (WHO) has reported that 5% of the world’s population is chronically infected with the hepatitis B virus (HBV), which is usually transmitted by contaminated blood, shared needles or sexual contact.
Current treatment options often have limited effectiveness, poor tolerability or resistance concerns. Hepatitis B drugs are also said to have limited sales potential, as infections usually occur in developing countries where strict price controls are enforced and where patients cannot afford medicines. In the Far East and parts of Africa, HBV can lead to cirrhosis of the liver and liver cancer.
Idenix and Novartis say their telbivudine drug is an oral nucleoside that inhibits second strand HBV DNA synthesis. This mechanism of action may be responsible for the rapid viral suppression associated with telbivudine treatment.
The companies anticipate that complete data from the study will be submitted at a meeting set up by the American Association for the Study of Liver Diseases (AASLD) in November.