Results of a phase I study of Hepabig-Gene, an investigational hepatitis B treatment of Green Cross Corporation (GC Pharma), were presented in a poster session at the 69th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) held on Nov 9-13 in San Francisco, the Korean biopharmaceutical company announced Wednesday.
Hepabig-Gene, an immune globulin produced by recombinant DNA technology, has a higher level of antibody purity and virus-neutralizing capability than existing plasma-derived treatments.
GC Pharma is developing Hepabig-Gene as a prophylactic to the recurrence of hepatitis B in liver transplant patients, while conducting a clinical trial to evaluate whether the drug is also indicated for the treatment of chronic hepatitis B infection.
The phase I study results confirmed the new drug’s efficacy and safety profile with varying dosages in the treatment of chronic hepatitis B virus infection. No major adverse events were observed even at the maximum dosage, and researchers confirmed the dosage and dose frequency to significantly reduce the amount of hepatitis B surface antigen (HBsAg) that will result in a true cure.
"The phase I study results showed the drug’s potential to maximize the level of curing in patients with yet-incurable chronic hepatitis B and we will evaluate the drug in a phase 2a study to deepen our understanding of how to maximize the treatment through a combination therapy with antiviral drugs,” said Dr. Ahn Sang-hoon, a Severance Hospital professor who has led the study.
By Kim Hye-soon and Minu Kim
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