Baxter completes enrolment for haemophilia drug trial

Baxter has announced the completion of enrolment for a phase III clinical trial of BAX 855, a promising investigational therapy for haemophilia A.

The extended half-life, recombinant factor VIII treatment is being trialled to assess its efficacy in reducing annualised bleed rates in both prophylaxis and on-demand treatment schedules, as well as its safety and pharmacokinetic profile.

It is based on the full-length Advate molecule, a product with ten years of real-world experience, and has been modified with PEGylation technology designed to extend its duration of activity in the body.

Over the course of the phase II/III PROLONG-ATE study, BAX 855 is being evaluated among 146 adult patients with previously-treated severe haemophilia A. Results from the trial will support planned regulatory filings in 2014.

Dr Anders Ullman, vice-president of global research and development in Baxter's bioscience business, said: "The BAX 855 development programme is a priority for Baxter as we evaluate the potential to provide an efficacious and safe treatment with an extended half-life for patients with haemophilia."

This comes after the firm submitted a marketing authorisation application to the European Medicines Agency for the haemophilia B therapy Rixubis last month.