Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) today announced that the first patient has been dosed with the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in a global registrational clinical trial. The study, called A-LONG, is an open-label, multicenter, Phase 2/3 study designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in previously-treated hemophilia A patients.
“Dosing the first patient in the A-LONG study is an important milestone in our progress toward developing a treatment that has the potential to make a difference for the hemophilia A community”
"Treatment of hemophilia A involves frequent injections that can often be a major burden for individuals with the disorder, as well as their families," said John Pasi, M.D., Co-Principal Investigator of the A-LONG trial and Professor of Haemostasis and Thrombosis, Barts and The London School of Medicine and Dentistry, London. "There is a significant unmet need for a Factor VIII product, like rFVIIIFc, with the potential to prolong protection from bleeding and yet reduce the frequency of infusions, as well as potentially reduce the complications of hemophilia and improve the quality of life for these patients."
rFVIIIFc is a fully-recombinant clotting factor developed using Biogen Idec's novel and proprietary monomeric Fc fusion technology. The A-LONG trial is designed to evaluate different dosing regimens of rFVIIIFc in the prevention of bleeding as measured by the number of breakthrough bleeding episodes over the study period. The study will also evaluate the efficacy of rFVIIIFc in on-demand and surgical settings, and compare the pharmacokinetics of a single dose of rFVIIIFc with a single dose of a commercially-available recombinant Factor VIII product (Advate,® antihemophilic factor recombinant, plasma/albumin-free method, rFVIII).
"Dosing the first patient in the A-LONG study is an important milestone in our progress toward developing a treatment that has the potential to make a difference for the hemophilia A community," said Glenn Pierce, M.D., Ph.D., Vice President and Chief Medical Officer of Biogen Idec's hemophilia therapeutic area. "This trial, along with the ongoing Phase 2/3 study of our fully-recombinant, long-lasting Factor IX Fc fusion protein for the treatment of hemophilia B, further demonstrates our strong commitment to developing better treatments for the worldwide hemophilia community."
"rFVIIIFc is an innovative therapy that offers the potential to make a positive impact in the lives of people with hemophilia A," said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum. "The initiation of this trial builds on the positive data that we saw in our Phase 1/2a study, and it is also an exciting achievement for Swedish Orphan Biovitrum."
SOURCE Biogen Idec