Phase Ia data on TMC435350 to be presented at AASLD
01-Oct-07 Medivir announced that their abstracts for the 58th Annual Meeting of the American Association for Study of Liver Diseases (AASLD) have been published today and are available on Hepatology web site (AASLD).
The two abstracts summarize the results from a phase I clinical trial and further preclinical data that will be presented by Medivir and Tibotec, on their investigational compound TMC435350, a hepatitis C protease inhibitor, at AASLD in Boston, Massachusetts, USA on November 6th, 2007. The two posters are titled “Results of a phase I placebo-controlled trial in healthy volunteers to examine safety, tolerability and PK of the protease inhibitor TMC435350 after single and repeated dosing” and “In vitro activity and preclinical PK of a potent HCV NS3/4A serine protease inhibitor, TMC435350”.
Data from the phase Ia clinical trial show that TMC435350 was well tolerated in single doses up to 600 mg and in 5 days of dosing up to 400 mg once-daily.
The project has advanced to phase Ib trials, where its ability to suppress virus in patients infected with Hepatitis C is being investigated following once-daily oral dosing.
“The successful outcome of the phase Ia clinical trial is the single most important milestone for Medivir so far this year” comments Lars Adlersson, CEO & President at Medivir.
Chronic infection with the hepatitis C virus (HCV) leads to liver diseases. According to the WHO, 3% of the global population is infected with HCV, which means 200 million individuals. In the USA, 1.8% of the population is infected, that is 3.9 million people. In more than 60% of these cases, the HCV infection leads to chronic liver disease, cirrhosis and liver tumors. It is the most common reason for liver transplant. The HCV market is currently dominated by interferon-based treatments.
For additional information, please contact
Rein Piir, CFO & Vice President Investor Relations, Medivir AB, +46 708 537292