Baxter’s investigational haemophilia treatment was successful in controlling bleeding episodes in a late-stage clinical trial with patients who develop inhibitors to clotting factor replacement therapies.
Phase III data show that recombinant factor BAX 817 resolved acute bleeding episodes at 12 hours with on-demand treatment regimens, with an overall success rate of 92%. Also, 89% of patients achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.
Crucially, no patients taking part in the trial developed inhibitors or binding antibodies to BAX 817, and none discontinued treatment due to an adverse event, the firm noted.
"The development of inhibitors remains one of the most significant challenges in treating haemophilia, as it may place patients at increased risk for life-threatening complications resulting from difficult-to-treat bleeding episodes," said John Orloff, global head of research and development at Baxter BioScience, highlighting the drug’s potential.
Full results are to be published at a medical meeting later this year, and Baxter is currently working on global regulatory submissions for its therapy.