Valeant says phase 2 trials indicate pradefovir mesylate more effective for hepatitis B than Hepsera

By E. Janene Geiss

Philadelphia, Nov. 15 - Valeant Pharmaceuticals International said interim results of a phase 2 study of its oral anti-viral compound pradefovir mesylate showed that the percentage of patients achieving undetectable HBV DNA was significantly greater for patients receiving pradefovir mesylate compared to those receiving Hepsera at doses of 10 mg, 20 mg and 30 mg QD.

Additionally, the data show that the pradefovir 30 mg QD cohort achieved a 5.02 log10 drop in viral titers from the baseline compared to a 3.66 log10 drop in the Hepsera group, according to a company news release.

"The 24-week interim results are excellent. These data suggest that pradefovir has the potential to be a 'best in class' option for those suffering from hepatitis B," said Kim D. Lamon, Valeant's president, research and development and chief scientific officer, in the release.

Pradefovir is a pro-drug of adefovir that was licensed from Metabasis Therapeutics. Pradefovir uses Metabasis' HepDirect technology that enables higher concentrations of the drug in the liver, the primary site of hepatitis B viral replication, officials said.

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 previously had been treated ineffectively with other drugs and 70 percent of the patients were HbeAg positive. Patients who had been previously treated ineffectively are considered more difficult to treat. The phase 2 study consists of five treatment groups at different dosing levels and Hepsera at 10 mg a day, with an overall treatment duration of 48 weeks.

Officials said there were no serious adverse events related to treatment. The most serious adverse events were similar across all treatment groups, including Hepsera. Patient participation is expected to be completed in early 2006. Phase 3 trials are expected in mid-2006, officials said.

Interim results were presented Monday at the Association for the Study of Liver Diseases annual meeting in San Francisco.

Valeant is a research-based pharmaceutical company in Costa Mesa, Calif.

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