ISU Abxis said Friday that Catalyst Biosciences, its U.S. partner, has begun the patient recruitment process ahead of its phase 2b clinical trial of dalcinonacog alfa(DalcA), a hemophilia B treatment candidate.
The two companies have been jointly developing the treatment since 2013. If approved, ISU Abxis will have exclusive sales rights in Korea and receive royalties based on global sales, excluding Korea.
The clinical trial conducted by Catalyst is an open trial which will assess whether DalcA subcutaneous injections can maintain blood Factor IX activity in patients with type B hemophilia by more than 12 percent. The company plans to enroll six patients and will subcutaneously inject the drug for 28 days.
The company also plans to monitor the safety, pharmacokinetics as well as tolerability and antibody response of the drug and plans to complete the research by the second half of this year.
“Test data from Clinical Trial 1 and 2 showed that DalcA was highly effective in treating type B hemophilia,” Catalyst Biosciences CEO Nassim Usman said. “Therefore, we expect that the activity of Factor IX will be maintained at more than 12 percent to prevent continuous bleeding.”
The company will further demonstrate safety and efficacy of subcutaneous injection of DalcA on Clinical 2b and expects that the treatment will enhance convenience as a subcutaneous injection and improve the quality of life of patients with type B hemophilia, Usman added.
<© Korea Biomedical Review, All rights reserved.>