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news.Valeant Pharmaceuticals' oral anti-viral compound pradefovir, for the treatment of compensated chronic hepatitis B, has posted positive 48 week results in a phase II study.
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Pradefovir is a pro-drug of adefovir that was licensed from Metabasis Therapeutics. Pradefovir uses Metabasis’ HepDirect technology which enables higher concentrations of the drug in the liver, the primary site of hepatitis B viral (HBV) replication.
The phase II study is an open-label, randomized, multiple dose study with 242 patients enrolled at 21 sites in the US, Taiwan, Singapore and Korea.
Results so far show that 10, 20 and 30mg of pradefovir had a statistically superior viral load reduction compared to 10mg dosages of Gilead Sciences’ Hepsera.
In the pradefovir treatment groups HBV DNA of less than 400c/mL was achieved in 45% of patients given a 5mg dose, 63% in the 10mg group, 56% in those given 20mg, and 71% of patients in the 30 mg group. This compares with 36% of patients given 10mg Hespera.
“In addition to the significant reductions in viral load seen at week 24, continued declines occurred through the end of the phase II study, demonstrating a potentially major advantage over existing therapy,” said Timothy Tyson, president and CEO.