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news.Biogen Idec and Swedish Orphan Biovitrum's fully-recombinant factor, IX Fc fusion protein (rFIXFc), in hemophilia B patients, was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies, in a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study.
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Biogen Idec and Swedish Orphan Biovitrum said that the Phase 1/2a study of rFIXFc in 14 previously-treated patients with severe hemophilia B (less-than or equal to 2 U/dL endogenous FIX), was designed as an open-label, multi-center, dose-escalation study to evaluate the safety and pharmacokinetics (PK) of a single dose of rFIXFc given as an intravenous injection.
The primary objective of the study was to assess the safety of rFIXFc at different doses; the secondary objective was to estimate the PK parameters of rFIXFc at doses ranging from 12.5 to 100IU/kg.
Biogen Idec and Swedish Orphan Biovitrum said that based on positive results from the Phase 1/2a trial, rFIXFc was advanced into a global registrational trial called B-LONG in January to assess the safety, pharmacokinetics and efficacy of rFIXFc in the prevention and treatment of bleeding in 75 previously-treated people with severe hemophilia B.
Amy Shapiro, medical director of the Indiana Hemophilia and Thrombosis Center, said: “Results from the Phase 1/2a trial show that rFIXFc may be able to reduce the number of injections to once weekly or less.”
Glenn Pierce, vice president and chief medical officer of hemophilia therapeutic area at Biogen Idec, said: “Developed using our new Fc-fusion technology, rFIXFc has the potential to improve the lives of individuals with hemophilia B by providing protection from bleeding.”
Peter Edman, chief scientific officer of Swedish Orphan Biovitrum, said: “We look forward to results from the registrational trial and are excited about the potential of rFIXFc to reduce the frequency of injections necessary for people with hemophilia B.”
Biogen Idec and Swedish Orphan Biovitrum are also developing a recombinant, long-lasting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A, making use of the same proprietary technology as rFIXFc.