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news.Biogen Idec and Swedish Orphan Biovitrum have dosed first patient with their long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in an open-label, multicenter and global registrational Phase 2/3 study A-LONG.
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rFVIIIFc is a fully-recombinant clotting factor developed using Biogen Idec‘s novel and proprietary monomeric Fc fusion technology.
The technology makes use of a natural mechanism that recycles rFVIIIFc in the circulation to extend its half-life.
It is a fully-recombinant clotting factor designed to replace the protein that hemophilia A patients lack and to last longer in the body than commercially-available Factor VIII products.
The study’s objectives are to evaluate the safety and tolerability of rFVIIIFc, which will be measured by evaluating clinically notable changes from baseline in physical examinations, vital signs, lab values, and incidence of adverse events and inhibitor development.
The study will also assess the potential of rFVIIIFc to enable protection from bleeding by evaluating the number of both spontaneous and traumatic bleeding episodes in each treatment arm.
Biogen Idec Hemophilia Therapeutic Area vice president and chief medical officer Glenn Pierce said dosing the first patient in the A-LONG study is an important milestone in their progress toward developing a treatment that has the potential to make a difference for the hemophilia A community.
Swedish Orphan Biovitrum chief scientific officer Peter Edman said that rFVIIIFc is an innovative therapy that offers the potential to make a positive impact in the lives of people with hemophilia A.
"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," Edman said.