Biopharmaceutical company CSL Behring has dosed the first patient in part 3 of its Affinity clinical trial programme, a Phase I/III pivotal study evaluating recombinant single-chain factor VIII (rVIII-SingleChain) for the treatment of haemophilia A.
The open-label, non-randomised multi-centre study is designed to assess the efficacy, safety and pharmacokinetic profile of rVIII-SingleChain versus recombinant human antihemophilic factor VIII (octocog alpha).
CSL global clinical research and development senior vice president Dr Russell Basser said; "As part of our ongoing commitment to the hemophilia community, we are developing and investigating innovative recombinant factor therapies for the treatment of both hemophilia A and B that have the potential to offer patients and caregivers significant advances in treatment and convenience of factor infusion."
A total of 27 subjects in the part 1 of the study were administered with a single infusion of 50IU/kg body weight (bw) of octocog alfa subsequent to a single infusion of 50IUkg bw rVIII-SingleChain.
At a dose and frequency determined by the study doctor based on underlying bleeding phenotype, the subjects in parts 2 and 3 of the study will be given infusions of rVIII-SingleChain to prevent and treat bleeding.
With a novel recombinant single-chain factor VIII design, rVIII-SingleChain leverages a strong, covalent bond to connect light and heavy chains to improve the stability and half-life of factor VIII (FVIII).