The rFIXFc program is partnered with Biogen Idec.
rFIXFc is a fully recombinant clotting factor designed to replace the protein that hemophilia B patients lack and to last longer in the body than commercially available Factor IX products. rFIXFc has been developed using monomeric Fc-fusion technology, which leverages a natural mechanism that recycles rFIXFc in the circulation to extend its half-life.
rFIXFc is the only long-lasting treatment option for hemophilia B, that is currently being evaluated in late-stage clinical trials. rFIXFc is being studied in a Phase II/III registrational, open-label, multicenter trial (B-LONG) designed to evaluate its safety, pharmacokinetics and efficacy in the prevention and treatment of bleeding in previously treated patients with severe hemophilia B.
For more information on the rFIXFc trial, please visit www.clinicaltrials.gov.
rFIXFc news
In January 2010, the first patients were dosed in the registrational, open-label, multicenter study, to evaluate the safety, pharmacokinetics and efficacy of the long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The trial, called the B-LONG study, will include approximately 75 previously-treated patients with severe hemophilia B.
On July 11, 2010, positive data from the Phase I/II study of the long-lasting, fully recombinant factor IX Fc fusion protein (rFIXFc) in 14 previously-treated patients with severe hemophilia B was presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina. The study design was an open-label, multi-center, dose-escalation study to evaluate the safety and pharmacokinetics (PK) of different single doses of rFIXFc given as an intravenous injection.
rFIXFc demonstrated an approximately three-fold increase in half-life (52.5±9.2 hours) compared to data reported in the literature for existing factor IX therapies. rFIXFc was generally well tolerated, and there were no signs of injection site reactions. During the three-month observation period, no anti-rFIXFc drug antibodies, and thus no inhibitor development, were detected. There were no reports of drug-related serious adverse events.