Baxter to commence late-stage trial of haemophilia A therapy

Baxter has announced plans to commence a late-stage trial of its new haemophilia A treatment BAX 855, following positive results from a phase I study.

Due to the promise of these early-stage assessments, the company has submitted the drug to the US Food and Drug Administration for approval and will start enrolment of adult patients for the phase II/III study in the first quarter of 2013.

BAX 855 is a promising full-length longer-acting recombinant factor VIII (rFVIII) developed to increase the half-life of Advate (Antihaemophilic Factor [Recombinant] Plasma/Albumin-Free Method), the world's most widely-used rFVIII therapy.

The compound was developed in association with Nektar Therapeutics and utilises proprietary PEGylation technology designed to extend the duration of activity of proteins.

Professor Hartmut Ehrlich, vice-president of global research and development in Baxter's BioScience business, said: "Baxter screened more than 100 molecules over several years and has selected one that has the potential to maintain the safety profile and meaningfully extend the half-life of Advate to allow for less frequent dosing."

Last month, the company reported positive data from a study of BAX 326, a recombinant factor IX protein that has been shown to be able to reduce the risk of bleeding among haemophilia patients.