Valeant's pradefovir reduces hepatitis B viral load during phase 2 study

By Elaine Rigoli

Tampa, Fla., March 16 - Valeant Pharmaceuticals International said the results from a phase 2 study of its oral antiviral compound pradefovir showed a statistically significant decline in hepatitis B viral DNA at 10 mg, 20 mg and 30 mg doses of pradefovir.

The phase 2 study is an open-label, randomized, multiple-dose study with 242 patients enrolled at 21 sites in the United States, Taiwan, Singapore and Korea. About half of the patients had been previously treated with interferon or an antiviral and are considered to be more difficult to treat, the company said.

Patients were randomized to one of five treatment groups: 5 mg, 10 mg, 20 mg or 30 mg of pradefovir per day or 10 mg per day of Hepsera (adefovir dipivoxil), with an overall treatment duration of 48 weeks.

The percentage of patients with hepatitis B viral DNA of less than 400 c/mL were 45%, 63%, 56% and 71% for the pradefovir 5 mg, 10 mg, 20 mg and 30 mg groups, respectively, and 36% for the Hepsera group, according to a company news release.

"We are excited that the strong interim data seen in the phase 2 trial were also seen in the final 48-week analysis," Timothy C. Tyson, president and chief executive officer, said in the release.

"In addition to the significant reductions in viral load seen at week 24, continued declines occurred through the end of the phase 2 study, demonstrating a potentially major advantage over existing therapy. We look forward to the initiation of phase 3 trials later this year."

Intended for the treatment of compensated chronic hepatitis B, pradefovir is a pro-drug of adefovir that was licensed from Metabasis Therapeutics.

Pradefovir uses Metabasis' HepDirect technology, which Valeant said enables higher concentrations of the drug in the liver, the primary site of hepatitis B viral replication.

Costa Mesa, Calif.-based Valeant is a specialty pharmaceutical company that discovers, develops, manufactures and markets pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology.

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