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发表于 2003-12-21 13:08
新药信息：IDENIX的telbivudine(LdT)进入I/II期临床
Sydney, AUSTRALIA, April 9, 2003
临床前动物模型实验表明，给药一周telbivudine (LdT) 可减少HBV平均病毒载量的90%。 目前已进入I/II期临床，并着手III期临床的注册工作。
http://www.idenix.com/press/030409.html
IDENIX PRESENTS POSITIVE HEPATITIS C AND HEPATITIS B RESULTS
- Positive data advance hepatitis C candidate into phase I/II trial and trigger start of phase III pivotal trial of telbivudine for HBV -
Sydney, AUSTRALIA, April 9, 2003 - Idenix Pharmaceuticals, Inc. today presented positive pre-clinical results of NM283, its hepatitis C virus (HCV) clinical drug candidate, at the 11th International Symposium on Viral Hepatitis & Liver Disease in Sydney, Australia. NM283, a ribonucleoside analog being developed as an oral, once-daily treatment, appeared to be well tolerated and after one week of treatment reduced mean viral load by over 90 percent (1 log10) in a primate model of human chronic HCV infection. Idenix also presented 24-week data from an ongoing phase IIb trial of telbivudine (LdT) for the treatment of hepatitis B virus (HBV) infection, further demonstrating its promising safety and antiviral efficacy. On the basis of these results, Idenix has advanced NM283 to phase I/II clinical development and initiated a phase III registration trial of telbivudine.
These data presentations follow Idenix's announcement in late March that it has entered into definitive agreements with Novartis Pharma AG, an affiliate of Novartis AG (NYSE:NVS), pursuant to which Novartis will acquire a majority equity interest in Idenix and will acquire rights to jointly develop and commercialize select Idenix drug candidates.
The NM283 preclinical study was conducted in a primate model with human-derived chronic HCV infection. NM283 was administered orally, once-daily for one week at either 8.3 or 16.6 mg/kg compared to placebo. HCV viral loads dropped rapidly in all treated animals after the first two days of dosing and fell further by day 7. Mean log10 viral load reductions at day 7 were 1.05 in the 16.6 mg/kg dose group and 0.83 in the 8.3 mg/kg dose group. In contrast, HCV titers were stable in the pre-treatment and placebo samples. NM283 appeared to be well tolerated throughout dosing. A phase I/II clinical trial of NM283 in patients with chronic hepatitis C is now underway, following the acceptance by the United States FDA of an Investigational New Drug Application.
"We believe that NM283 is the first small molecule antiviral agent shown to be effective in this primate model of chronic HCV infection", said David Standring, Ph.D., Idenix's Vice President of Biology. "These results suggest that further development of this potentially important new treatment for chronic hepatitis C is warranted."
The phase I/II clinical trial of NM283 will evaluate safety and antiviral activity in adults with genotype 1 HCV infection to determine optimal dosing levels of NM283 for future clinical trials. This short-term dose-escalation trial is being conducted at a number of sites in the United States.
HBV Program - Telbivudine
Data from an ongoing phase IIb clinical trial of telbivudine (LdT) for the treatment of chronic hepatitis B were also presented today by Ching-Lung Lai, M.D., Professor of Medicine at the University of Hong Kong and a principal investigator in this study. This randomized, blinded, international multicenter phase IIb clinical trial, in 104 adults with HBeAg-positive chronic hepatitis B, compares the safety and antiviral efficacy of telbivudine, and telbivudine in combination with lamivudine, to a control arm of lamivudine alone. All patients are being dosed orally, once-daily for a treatment period of 52 weeks.
Average reductions in serum virus load were greater than 6 log10 for all trial groups receiving LdT, significantly greater than the 4.67 log10 reduction observed with lamivudine alone. Serum HBV became undetectable in twice as many patients receiving LdT monotherapy, compared with lamivudine monotherapy, as determined by a highly sensitive polymerase chain reaction (PCR) assay (32% and 16%, respectively). Within 12 weeks of treatment, 49% of patients receiving LdT monotherapy had normalized serum alanine aminotransferase (ALT), indicating reduced liver inflammation. By week 24, ALT had normalized in 75% of patients receiving LdT monotherapy. LdT treatments have been well tolerated, with no treatment-related or dose-limiting adverse events observed. Final 52-week phase IIb data are expected in the fall of this year.
These promising data support the initiation of a large-scale international phase III clinical trial, currently underway. This pivotal registration trial, enrolling 1,200 patients worldwide, will evaluate the safety and efficacy of telbivudine compared with lamivudine, in patients with HBeAg-positive and HBeAg-negative compensated liver disease.
Idenix recently announced that it had entered into definitive agreements with Novartis Pharma AG. Upon closing of the agreements, Novartis will acquire 51% of the issued and outstanding shares of Idenix and rights to jointly develop and commercialize Idenix's hepatitis B clinical drug candidates. Novartis will also have the option to acquire rights to Idenix's hepatitis C drug candidates.
About hepatitis C:
There are approximately 170 million people worldwide with chronic HCV infection, of which approximately 3 million are in the United States. HCV accounts for 30% of end-stage liver disease and liver cancer, 20% of cirrhosis cases and is the leading cause of liver transplant. Available treatment options are limited in their effectiveness and safety. Additionally, these therapies are less effective in patients infected with HCV genotype 1, a specific strain of HCV that is the most prevalent and most treatment-resistant HCV genotype found in the US, Japan and Western Europe.
About hepatitis B:
There are approximately 350 million people worldwide with chronic hepatitis B virus infection, of whom approximately 33% have potentially progressive and life-threatening liver disease associated with their chronic HBV infection. Chronic hepatitis B can lead to cirrhosis, liver failure and hepatocellular carcinoma (liver cancer). Globally, hepatitis B accounts for over one million deaths annually, making it the ninth leading cause of death worldwide.
About Idenix:
Idenix Pharmaceuticals is engaged in the discovery and development of selective and specific, small molecule drug candidates which may be administered orally, once-daily, alone or as components of combination drug therapy for infectious disease. The Company is headquartered in Cambridge, Massachusetts and has drug discovery operations in Montpellier, France and Cagliari, Italy. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). For further information, please refer to http://www.idenix.com.
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