PharmaEssentia Corp (藥華醫藥) yesterday said it had gained approval from the Food and Drug Administration to proceed with a phase III global clinical trial to add hepatitis B as an indication for ropeginterferon alfa-2b, its newly approved polycythemia vera (PV) drug.
The company is planning to enroll 212 e-antigen positive hepatitis B patients worldwide and complete the phase III trial over the next two to three years, it said.
The announcement came after the European Medicines Agency earlier this week gave marketing authorization for the PV drug in the eurozone.
The parameters of the clinical trial leverages biomarkers to identify patients who are more likely to respond to the company’s interferon drug, PharmaEssentia chief executive Lin Ko-chung (林國鐘) said.
Hepatitis B is a highly contagious disease with more than 400 million chronic carriers worldwide and it leads to 1 million deaths a year, the company said.
There are between 10 million and 30 million new cases each year, and between 5 and 10 percent are likely to be hereditary carriers that do not show symptoms of the disease due to their genetic traits.
Studies show that 30 percent of the hereditary carriers with high concentrations of hepatitis B core antigen are likely to respond well to interferon treatments, the company said, noting that its phase III trial is targeting those patients.
Chronic infections such as hepatitis B are currently treated with nucleoside analogs or long-acting interferons such as Roche Holding AG’s Pegasys, but each has its shortcomings.
Nucleoside analogs have high toxicity profiles and only suppress the disease, while Pegasys has limited effectiveness and requires frequent injections.
Phase I and II trials showed that compared with Pegasys, PharmaEssentia’s interferon produced shorter seroconversion periods — the time it takes for patients to develop antibodies against e-antigen that can be detected in blood tests — among select patients, it said.
The interferon requires only biweekly injections and has milder side effects, and could be an option to meet currently unmet medical needs, the company said.
The company said it is working on the phase III trial with Linkou Chang Gung Memorial Hospital and Keelung Chang Gung Memorial Hospital.
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