ISU Abxis said that it has started phase 1 clinical trial of Abcertin, an enzyme replacement therapy for Gaucher disease, in Australia.
The drug has the same ingredient as Sanofi Genzyme's Cerezyme and received approval in Korea in 2012. The company is exporting the drug to foreign countries, such as Iran and Mexico.
The company decided to use the clinical trial as a strategy to expand the drug's access to the European market. To receive drug approval in Europe, the company will conduct a trial similar to that of a biosimilar than an orphan drug.
The study will compare safety, tolerability, and immunogenicity in 40 healthy adults based on a comparison of pharmacokinetics between Abcertin and Cerezyme.
The goal is to complete phase 1 clinical trials next year and enter phase 3 global clinical trials by 2021.
Gaucher's disease is a genetic disease caused by the lack of beta-glucocerebrosidase, an essential enzyme in the body. When the enzyme is deficient, glucocerebroside cannot be broken down and accumulates in the spleen, liver, and bone marrow, causing symptoms such as anemia, platelet loss, hepatomegaly, and bone marrow infiltration, and sometimes neurological problems.
"As Gaucher's disease patients in Korea and abroad have been continuously taking Abcertin for at least five years, the company expects to see no problem in confirming the equivalence between Abcertin and Cerezyme," a company official said. "We are planning to complete the trials as soon as possible to help patients suffering from Gaucher's disease worldwide."
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