Biogen Idec and Swedish Orphan Biovitrum have decided to advance their fully-recombinant Factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial to treat people with haemophilia A.
The registrational trial will evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc for both the prevention and treatment of bleeding in haemophilia A.
It will also study the ability of rFVIIIFc to prolong protection from bleeding and reduce the frequency of injections.
A Phase I/IIa study demonstrated that rFVIIIFc prolonged half-life in people with severe haemophilia A compared to Advate across all patients and dose levels.
The dose-escalation study on 16 previously-treated patients evaluated the safety of rFVIIIFc at different doses and the pharmacokinetic parameters of rFVIIIFc at doses ranging from 25 to 65IU/kg.
Pharmacokinetic measures such as mean residence time and area under the curve increased with the use of the intravenous rFVIIIFc injection.
In the single-dose study, there were also no drug-related serious adverse events, no signs of injection site reactions and inhibitor development or anti-rFVIIIFc drug antibodies.
