Biogen and Sobi announced that they will be presenting updated and long-term data on two approved hemophilia treatments, Eloctate (marketed as Elocta in Europe) for hemophilia A, and Alprolix for hemophilia B, at the World Federation of Hemophilia (WFH)’s 2016 World Congress next week.
Specifically, data from separate Phase 3 extension studies evaluating each treatment’s safety and efficacy over time will be revealed in oral and poster presentations at the congress, taking place July 24–28 in Orlando, Florida.
Eloctate and Aplrolix are approved Fc fusion therapies that provide extended protection against bleeding episodes. According to the companies, Fc fusion technology uses a naturally occurring pathway to prolong the time the therapy remains in a patient’s body.
Eloctate, a recombinant clotting factor VIII therapy, treats hemophilia A by fusing that factor to the Fc portion of immunoglobulin G subclass 1, a common protein also known as IgG1. Widely approved, the treatment is in use in the U.S., Canada, Australia, New Zealand, Japan, the E.U., Switzerland, Iceland, Lichenstein, and Norway. Interim results from the extension study, ASPIRE, were reported by Biogen in August 2015 and found that both adults and children on extended-interval prophylaxis regimens with Eloctate experienced low bleeding rates.
Alprolix is a recombinant clotting factor therapy for hemophilia B that fuses factor IX to the Fc portion of IgG1. Alprolix is approved in the U.S., Canada, Japan, Australia, New Zealand and, most recently, the E.U., Iceland, Lichtenstein and Norway. Its long-term safety and efficacy was evaluated in the B-YOND study, and in its EU approval for use in children and adults, the therapy was found to offer prolonged protection against bleeding episodes with fewer prophylactic injections, according to a Biogen release in May 2016.
Post-hoc analyses to be presented include a longitudinal evaluation of joint health from patients participating in the trials, since most bleeding events in severe hemophilia A and B occur in the joints. The companies will alsopresent preclinical pharmacokinetic data from intravenous and subcutaneous administration of a recombinant fusion protein (FVIIIFc-VWF-XTEN) currently under investigation for the treatment of hemophilia A and using XTEN technology.
“The breadth of research, for both marketed products and preclinical programs being presented at WFH reflects our commitment to hemophilia and our mission to improve the lives of people living with hemophilia.” Rob Peters, Biogen’s Vice President of Rare Disease Research, stated in a press release.
“ELOCTATE and ALPROLIX are backed by robust clinical data and significant real-world experience. We believe these new data presentations will help healthcare providers to deepen their understanding of the clinical value and utility of these innovative medicines,” added Krassimir Mitchev, MD, PhD, Sobi’s vice president and medical therapeutic area head of Hemophilia.
Biogen and Sobi are collaborating in the development and commercialization of both treatments.