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Phase 3 Trial of Telbivudine Reaches Efficacy Endpoint
The largest hepatitis B registration trial to date, GLOBE enrolled more than 1,350 patients in over 130 medical centers worldwide. The ongoing trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in patients with HBeAg-positive and HBeAg-negative compensated chronic hepatitis B for two years of treatment in two daily treatment regimens: telbivudine 600 mg or lamivudine 100 mg.
The one-year analysis of this trial will be the primary data used for preparing the marketing registration applications. Idenix and Novartis plan to file with the U.S. Food and Drug Administration (FDA) by the end of 2005 for marketing approval of telbivudine for the treatment of chronic hepatitis B. Worldwide marketing filings, including the filing that will be submitted to the European Medicines Agency (EMEA), are expected in the first quarter of 2006. Idenix and Novartis are co-developing telbivudine.
The World Health Organization (WHO) has estimated that approximately 350 million people, or 5% of the world's population, are chronically infected with hepatitis B virus (HBV). Current treatment options are often associated with limited efficacy, poor tolerability or resistance concerns, and new therapeutic options are needed to respond to the significant unmet need in treating chronic hepatitis B.
"We are very pleased that telbivudine met the primary endpoint in the phase III GLOBE study and may provide an important new therapeutic option for patients with chronic hepatitis B," commented Nathaniel Brown, M.D., executive vice president of clinical development and chief medical officer of Idenix. "Bringing our first clinical candidate through this stage of development is a major milestone for Idenix, particularly given the large international scope of the GLOBE study."
The companies anticipate that complete data from the GLOBE study will be submitted for presentation to the American Association for the Study of Liver Diseases (AASLD) meeting in San Francisco, California, November 11-15, 2005.
More About Telbivudine
Telbivudine is a specific and selective, oral, once-daily nucleoside that is unique in its preferential inhibition of 2nd strand HBV DNA synthesis. This distinct mechanism of action may be responsible for the rapid and profound viral suppression associated with telbivudine treatment.
The GLOBE study results continue to support a favorable overall safety profile for telbivudine with no substantial safety issues being identified to date through the combined two years of treatment in the phase IIb clinical trial and in the phase III clinical program to date. The most frequently reported adverse events, regardless of attributability to study treatment, were upper respiratory infection and fatigue, which were equally common for telbivudine (14% and 12 %, respectively) and lamivudine (13% and 10% respectively).
An additional phase III trial is evaluating the safety and efficacy of telbivudine compared to lamivudine in HBeAg-positive and HBeAg-negative patients with decompensated chronic hepatitis B. This ongoing trial has enrolled 87 patients to date.
About Hepatitis B
Chronic Hepatitis B is caused by a virus that attacks the liver. The virus, which is called hepatitis B virus (HBV), can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. The WHO estimates that annually over 50 million people become infected with HBV and that more than one million individuals die from HBV-related chronic liver disease.
Source: Idenix Pharmaceuticals, Inc.