Baxter International has reported top-line results from its BAX 855 Phase III clinical trial, which is an investigational and extended half-life recombinant factor VIII (rFVIII) treatment for haemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].
The study has met its primary end-point in reducing annualised bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm, according to the company.
The study revealed that BAX 855 has controlled and prevented bleeding, routine prophylaxis, as well as managed perioperative in patients who were 12 years or older.
Baxter noted that patients in a twice-weekly prophylaxis arm experienced a 95% reduction in median ABR as compared to those in the on-demand arm.
Baxter BioScience vice-president and research and development global head John Orloff said: "The positive results of the BAX 855 study reflect our ongoing, long-term commitment to drive innovation and expand treatment options for patients with haemophilia."
The company has evaluated BAX 855 among 138 adolescent and adult patients previously-treated for haemophilia A.
The main objective of the study was the reduction in ABR during the treatment period compared to the on-demand treatment.
In addition, the study has assessed the safety and immunogenicity of the compound when administered on either prophylaxis or on-demand treatment regimens.
Baxter plans to submit a biologics licence application (BLA) for BAX 855 to the US Food and Drug Administration (FDA) by the end of this year.
The company is also starting a Phase III, prospective, open-label, multi-centre study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe haemophilia A, in addition to the ongoing study.
ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product, which is processed without any blood-based additives and is indicated for use in children and adults with haemophilia A.