PROLOR Biotech, Inc., today reported positive results from a comparative study of its biobetter longer-acting version of the hemophilia drug Factor IX (Factor IX-CTP) in Factor IX-depleted hemophilic mice. The study was designed to measure the potential increase in clotting activity and duration of therapeutic effect of PROLOR's long-acting CTP-modified Factor IX when compared with commercially available recombinant Factor IX. Factor IX is indicated for the treatment of acute bleeding episodes and as therapy for prevention of bleeding in hemophilia B patients.
In the study, Factor IX-CTP, when compared with commercially available Factor IX, demonstrated a significantly longer duration of clotting activity in the hemophilic mice model. Bleeding episodes were also significantly shorter and less intense for the group treated with Factor IX-CTP. In addition, none of the animals treated with Factor IX-CTP had any spontaneous re-bleeding events, compared with a 50% incidence of re-bleeding events for the group treated with commercial Factor IX and an 83% incidence of re-bleeding events for the untreated group.
The new study results support previous preclinical studies that demonstrated significant improvements in the half-life of Factor IX-CTP compared to commercially available Factor IX.