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New haemophilia data at ISTH congress to highlight extension study outcomes and paediatric use


18 June, 2015  

Swedish Orphan Biovitrum AB and collaboration partner Biogen will present 23 company-sponsored platform and poster presentations at the International Society on Thrombosis and Haemostasis (ISTH) 2015 congress taking place in Toronto, Canada, 20–25 June 2015.

The data presented underscore the companies’ ongoing commitment to haemophilia through continued research within the joint development programmes in haemophilia.

Data presented will include a late-breaking platform presentation from the Kids B-LONG study detailing the safety and efficacy of Alprolix/rFIXFc [Coagulation Factor IX (Recombinant), Fc Fusion Protein] in children with haemophilia B. This is the first time full results from the Kids B-LONG study will be publicly presented. An interim analysis from the ASPIRE study will also be presented focusing on the long-term safety and efficacy of Eloctate/Elocta/rFVIIIFc [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for the prevention and treatment of bleeding in previously treated adults and adolescents with haemophilia A. ASPIRE is a multi-year extension study for people who completed the pivotal, Phase III A-LONG or Kids A-LONG studies.

Our presentations at ISTH will contribute to advance medical scientific insight in the haemophilia community,” said Birgitte Volck, senior vice president, Chief Medical Officer at Sobi. “We believe that the comprehensive, growing body of Eloctate/Elocta and Alprolix clinical evidence will provide clinicians with a greater understanding of the potential these product candidates may have to improve care for people with haemophilia.

Eloctate and Alprolix have the potential to improve clinical outcomes and extend the interval between prophylactic injections. (1,2) They were developed using a process called Fc fusion, which was designed to prolong a therapy’s circulation in the body using a naturally occurring pathway. While Fc fusion has been used for more than 15 years, Biogen and Sobi are the only companies to apply it in the haemophilia space.

Highlights of Sobi and Biogen’s data at the meeting:

Eloctate/Elocta-focused abstracts
Safety and efficacy of recombinant factor VIII fusion protein (rFVIIIFc) for the prevention and treatment of bleeding in previously-treated adult and adolescent subjects with haemophilia A: Interim analysis of the ASPIRE study – Poster #235
Monday 22 June, 17:30–18:15 EST
Treatment of bleeding with recombinant factor VIII Fc fusion protein in previously-treated paediatric subject with haemophilia A in the Phase III Kids A-LONG study – Poster #239 – Monday 22 June, 17:30–18:15 EST
Indirect comparisons of factor consumption, bleeding rates, and infusion frequencies during routine prophylaxis with recombinant factor VIII Fc fusion protein and other recombinant factor VIII products – Poster #170 – Monday 22 June, 17:30–18:15 EST

Alprolix-focused abstracts
Study of recombinant factor IX Fc fusion protein in children with haemophilia B – late breaking oral session #009 – Wednesday, 24 June, 08:45-09:00 EST
Indirect comparisons of factor consumption, bleeding rates, and infusion frequencies during routine prophylaxis with recombinant factor IX Fc fusion protein and other recombinant factor IX products – Poster #171 – Monday 22 June, 17:30–18:15 EST

Clinical haemophilia abstract
A retrospective study on the current treatment practice of haemophilia A and B in the United Kingdom – Poster #299 – Wednesday 24 June, 17:30–18:15 EST
Full session details and data presentation listings for the 2015 Congress can be found on the ISTH website at https://www.isth.org/page/2015Microsite/.

References:

  1. Shapiro et al. J Thromb Haemost 2014;12(11):1788–1800.
  2. Powell et al. Br J Haematol 2015;168(1):113–23.